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<p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">11月7日，上海食药监局一口气公布了20起医疗器械产品召回情况。</span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">从企业来看，此次召回的云集了众多知名品牌，如：<span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">强生、柯惠、通用、</span>罗氏、飞利浦、碧迪、施乐辉、<span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">奥利巴斯、贝朗、库克等。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">据第一医械资讯统计，此次召回<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">包括2项I级召回，11项II级召回，7项III级召回。</span>其中，2项I级召回涉及的企业分别为库克（中国）医疗贸易有限公司和奥林巴斯贸易（上海）有限公司。飞利浦（中国）投资有限公司的召回报告有2则。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为了让大家更好了解详情，第一医械资讯特将此次召回具体情况整理如下：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">1、强生（上海）医疗器材有限公司对电生理导航系统主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">强生（上海）医疗器材有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司发现涉及产品在医院之间转移后，未按照说明书规定，在下次使用前进行相应的测试，这可能对系统运行造成不良影响。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司主动召回相关产品，安排技术人员对所有受影响机器重新测试，确保系统一切正常并获得相关技术服务报告。召回级别为II级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.2953125" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkfeUUPOF2XO9XLQppyWbicQRYetabwwRzXSYRJM6qzpOxxSPGlibAd9Pw/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.34375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibk6qfy7zeW54nh5Qaf1GWCBNVh3Fb84iaPTViat70QytjNxTA2HpbtGG8A/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /><img data-ratio="0.859375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkjcUgF3OPQvhpZFS5XkfX7GGeLpjwe7fXcmSgCW3EGP19XibSJvma70w/640?" data-type="jpeg" data-w="640" style="line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.1375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibk7p4yv9gSjgTWguCBIUBGQYtraOUSZfph7mqQjnhGxFSta2xvvZJvKQ/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">2、柯惠医疗器材国际贸易(上海)有限公司对呼吸回路主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">柯惠医疗器材国际贸易(上海)有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司发现实际进口到中国的呼吸回路产品与当时注册产品存在部分材质上的差异，不符合法规要求。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，本次召回级别为III级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-ratio="1.25" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibk2BB22P6tBXglMFc6xVrRZghibFdDJxNlic3vG6HO7JVQiagMz83OaHzzw/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">3、通用(上海)医疗器材有限公司对跟腱缝合导向器主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">通用(上海)医疗器材有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业发现，涉及产品的无菌外包装可能无法保证在声称的灭菌有效期内保持其密封的完整性，影响产品内包装外表面保持无菌。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，回收相关产品。本次召回级别III级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.1875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkYoIdJPPiaBTcmaTvcDJibwneSO59C6dmqiacnVEdNxRatK9f5xQLgkLicw/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">4、罗氏诊断产品（上海）有限公司对全自动血气、电解质和生化分析仪主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">罗氏诊断产品（上海）有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业发现，涉及产品在检测新生儿血液样本时，可能会由于样本吸入测量池时延迟或样本未完全吸入，导致后续分析软件无法正确处理，进而得到错误偏低的新生儿胆红素检测结果。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，向用户发放告知信，并将进行软件升级。本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.5203125" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkkkxanWK4nHC05yhNUwT5LqsI5KaoPZ3xFPVXia3e8c8ZjdeyPmhXDTg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">5、飞利浦（中国）投资有限公司对病人监护仪主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">飞利浦（中国）投资有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">当本地设置为“报警开启”的出厂默认设定修改后，涉及产品将禁止ECG报警生成并传输至PhilipsIntelliVue信息中心PIICiX，并且PIICiX上不会显示ECG报警已禁用。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，对受影响产品进行软件升级。本次召回级别为Ⅱ级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.409375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibksT6Q5icjiaaSuJWVfY8UfYOItwCRiciamIP1mMJMfQNmQhTtYb5ibjQ4tlg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.9875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkmyvQEge1NsPeAtBxQQ4AVcFuGZeGnnBMApgIrkPeINa3w3hTQXrhiaA/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">6、飞利浦（中国）投资有限公司对X射线计算机体层摄影设备、X射线计算机断层摄影设备主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">飞利浦（中国）投资有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业发现在执行高分辨率头部扫描时，所重建的图像可能会出现图像质量降质。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，对涉及产品进行软件升级。本次召回级别Ⅲ级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.4046875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkl9icVb9PM7CicUvQzZOFOpf0DdAKpfHC2eiajysXzo1TyiatcIqXt8kibAw/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.7109375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkU4SiaO8eMfjwPbZsTcTiakZutI9hk9iaxP8fquYuDz1USibAFJPnx7LicXQ/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">7、碧迪医疗器械(上海)有限公司对动脉采血器主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">碧迪医疗器械(上海)有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司发现部分产品无菌包装开裂，不能保证产品无菌。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司主动召回相关产品，通知相关单位收回受影响产品。召回级别为II级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-ratio="1.2765625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkd0NrXibV0tQic79QOP1MB6HuibVLpnqMh3SfoXicfZGmYkuj2evtibv2SBQ/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">8、施乐辉医用产品国际贸易(上海)有限公司对半髋关节假体组件主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">捷迈（上海）医疗国际贸易有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">由于生产过程中的错误，受影响产品的卡环沟槽位置尺寸超出产品设计要求，可能影响产品正常使用。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.4375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkWS2SwjhxiapkO37aqy9nyjibjU7CZ1goWQrruh62mx8aWIGl8iaiamJ59Q/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.296875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkHzdhCQU1vlg3O5k17OUzH0W3ZHt5RRcS68PVwzDomQTZClm2zHYf9w/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">9、奥林巴斯贸易（上海）有限公司对电子十二指肠镜主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">奥林巴斯贸易（上海）有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司收到来自美国市场关于电子十二指肠镜发生病人感染病毒的投诉信息。经调查，这可能与电子十二指肠镜清洗消毒不彻底有关。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司主动召回相关产品，停止使用相关产品，现场指导清洗消毒操作要点，现场修理涉及产品。召回级别为I级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-ratio="1.478125" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkojrlz8nicopuPBlWyBC5l53ufWr1UzibnUqAZp59XL875ib48FIuLlTcw/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">10、贝朗医疗(上海)国际贸易有限公司对一次性使用连续腰麻导管套件主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">贝朗医疗(上海)国际贸易有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司内部检测发现涉及产品的聚氯乙烯膜可能有空隙，影响无菌屏障系统。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，向用户发出通知，冻结库存产品，回收客户未使用产品。本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.334375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibksjU5q1ygFOQkg6gX5XLE6XDvib93AduIXdAJJzCBFmQMz4G40LH5cTg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.7671875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkSKAoxDWjibfW6mgIp0VCs8oI5KlicxHC7EefAXvAruKAokyroMnUia8lg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">11、库克(中国)医疗贸易有限公司将亲水涂层导丝召回等级变更为一级</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">库克（中国）医疗贸易有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司将亲水涂层导丝召回等级由二级升级为一级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.5" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkvgfu0nUEXNPoPUWVnXTe4X36DexGBcdmjicDBtaIbO773o4MwtG9jlg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.3109375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkV4z8aS5TjKLVmbCrDAeEbZ4dQwpa0ARDfw3ppxD4ia4YDcFCkPwqLUg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">12、宾得医疗器械(上海)有限公司对电子十二指肠内窥镜主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">宾得医疗器械(上海)有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">部分电子十二指肠镜结构复杂，如果未能按照使用说明书指示进行清洗和消毒，会导致污染未能及时被清除，增加病人感染风险。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司主动召回相关产品，向客户发通知函，强调实施规范清洗和消毒的必要性，现场监督和指导清洗消毒操作要点。召回级别为II级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.215625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkH5GuOPSBsW48NjnJEHibpxvPIvoMkSicVRkwoMMY9nn2UFZe3hwJdXVw/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.0765625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkrfS5hzlPnnaneyoiaBSpovXKGp11gYG7NHrTQwictDM4UbtmCldVKjhg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">13、捷迈(上海)医疗国际贸易有限公司对椎间融合器辅助工具主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">捷迈(上海)医疗国际贸易有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">产品说明书所列的清洗和去污方法，不能保证产品彻底清洗和去污，可能导致病人感染危险。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回产品，修改产品说明书，对客户进行相关培训。本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.265625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkZarpmzPHfzQVrXp2mQ2DDxQAbsHMkYXbdEn2H1fcoWsG3Pk3qJSMJg/640?" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; width: 670px !important; visibility: visible !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.546875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkwaq5dg93b9P0t8xWcpqrWOA6x4P8qcUmkb5xF2cvFBkBobRrm5AQlw/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">14、贝克曼库尔特商贸(中国)有限公司对总铁结合力样本预处理柱试剂盒主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">贝克曼库尔特商贸(中国)有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业发现，总铁结合力样本预处理柱试剂盒的注册证、中文说明书和中文标签中的存储温度与英文标签中标注的存储温度不一致。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，本次召回级别III级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.4546875" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkQIKJWPvJD0olQGmeHg558UdrPfsx25DJbiaoqrG1Yzh3Vv9p5LYMKUA/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.4296875" data-s="300,640" data-type="jpeg" data-w="640" width="100%" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkAibp2avl5evFkYIQSt7StLNgUuhntGFSsUKiayWic5Miaib4eSxiaoBnhBMw/640?" style="height: 287.891px !important; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670px !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; color: rgb(255, 41, 65); text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; color: rgb(255, 41, 65); text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">15、伯乐生命医学产品(上海)有限公司对凝血质控物主动召回</strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">伯乐生命医学产品(上海)有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">凝血质控物水平1，可能无法满足说明书上所示的开瓶后存放在2-25度的要求。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，对于水平1的开瓶说明进行补充说明。本次召回级别III级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.2859375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkyNTAJkSIZxXpdCD5hb6Palqy3699ZSYNZRo5JFKN2vkv4Kl3aeNIwA/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">16、上海上医康鸽医用器材有限责任公司对部分灭菌后产品主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">上海上医康鸽医用器材有限责任公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业灭菌柜控制软件更新升级，灭菌参数做了调整，但企业未对灭菌过程进行再确认，不能保证灭菌产品无菌。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.3640625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkwwlbM1IIm34XaaL8q2zEJD2A0emoloqHyouQg8vOia3a5lPCBUlYbrg/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.6578125" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibksOeRGtOdvhGXCLbBv2gCflPCp1QEbTU7dBkP8gQ6Y3lGlPQSmaibxTw/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="0.6890625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibk8LeuaCUfsN7DtLzJMjic8u0CukW7fOicIylKMnpVQCWv0mxlwKicCFftg/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">17、上海卫康光学眼镜有限公司对软性亲水接触镜主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">上海卫康光学眼镜有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业收到《国家医疗器械抽验产品检验结果送达告知书》，涉及产品“总直径”不合格。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，本次召回级别III级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.509375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkbFUtribtZhyad7kkOAd7Slm0uBqE3gIbZQF4JKicnFfFZF3D0MSQcM9Q/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">18、眼力健(上海)医疗器械贸易有限公司对聚丙烯酸酯类后房型人工晶状体、折叠式后房丙烯酸人工晶体主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">眼力健(上海)医疗器械贸易有限公司报告：<span style="max-width: 100%; line-height: 1.6; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业发现一台检验设备故障，导致部分人工晶状体在放行前未进行全部项目检查。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">这可能导致贴有错误标签的产品被放行，使用错误标签的人工晶状体可能导致潜在的非预期的术后屈光不正。公司决定召回相关产品，本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-ratio="1.5328125" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkfdxCA9ScVYFSdXuJ3v8UF1A2yIXc5aRlGmiciauoRzibYwTj0JM8bhj8Q/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; text-align: justify; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">19、索灵诊断医疗设备(上海)有限公司对雌二醇测定试剂盒(化学发光免疫法)主动召回</span></strong></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">索灵诊断医疗设备(上海)有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">企业发现，氟维司琼可能与雌二醇测定试剂盒发生交叉反应，导致雌二醇检测结果假性升高。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，在产品说明中增加相关警示说明。本次召回级别II级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1.375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibkw274FraXthicOwB7CPaRhqePgX0Jbk5RicKFnWJPNWTxVJ6EibCIvz8jA/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; line-height: 1.6; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">20、迈柯唯（上海）医疗设备有限公司对手术床系统主动召回</span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">迈柯唯（上海）医疗设备有限公司报告：<span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">公司发现制造适配器的材料未能达到公司规定的要求，不符合产品设计强度要求，影响患者使用安全。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">公司决定召回相关产品，向用户发出通知，并免费更换受影响的电路板。本次召回级别III级，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-ratio="1.5734375" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/SLP8enbs6ibiahicNaYudhllicY1T1dwicQibk18oOg9dLrUpznDicyicDwIEgxlQ1jr9EKvpWMnKZ44wYaylOfQzG4icow/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%" /></span></p><p><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">地址：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 </span><span style="font-size: 14px; line-height: 1.75em;"> </span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="font-size: 14px; line-height: 1.75em;">邮编：510507</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电话：(+86)020-8722 8723 8764 5360 8764 2943 </span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">传真：020-8722 8623</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">全国统一免费服务热线：400-020-6788</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">微信公众帐号：</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">维修咨询：QQ: 712638 404</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">设备咨询: QQ: 712638 405</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">软件咨询：QQ: 712638 406</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">配件咨询：QQ: 712638 407</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">交流Q群：1106 11074</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">网址：http://www.yiliaoshebeiweixiu.com</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电子邮箱：service@yiliaoshebeiweixiu.com</span></p><p><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p><p><br /></p>
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发表于 2020-10-19 23:40:50