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<p style="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);">最近，全国部分地区针对进口的超声诊断仪进行了大排查，主要排查GE、飞利浦产品遭假冒和翻新的问题。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; 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(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">国家质检总局发排查通知</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">赛柏蓝器械获悉，近日，国家质检总局下发了一个通知――－《关于查出多批次进口超声诊断仪涉嫌假冒和翻新情况的警示通报》【质检检函（2016）151号】。该通报指出，陕西、深圳、江苏、北京、上海、广东等地陆续发现部分企业进口的GE、PHILIPS品牌彩色超声诊断仪存在假冒和翻新问题。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">国家局警示通报还列出遭假冒和翻新的品牌产品和黑名单中的供货商、收货人信息，以便各地进行排查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; 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(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">深圳首次查获涉嫌假冒品牌医疗器械</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">据广东当地媒体消息，今年5月底至6月中旬深圳检验检疫局陆续对进口的一批某知名品牌彩色超声诊断系统进行检验并跟踪调查，发现该系统存在多项货证不符、安全项目不合格等情况，涉嫌假冒某全球知名品牌医疗器械。这也是该局首次查获涉嫌假冒品牌医疗器械。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">深圳局查获的上述彩色超声诊断系统进口自香港，产地为奥地利。该产品多处不符合《医疗器械监督管理条例》《医疗器械说明书和标签管理规定》等相关规定，包括：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); 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%; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">一是其机身上标注进口注册证号与企业提供的医疗器械注册证书的注册证号不一致，且机身上标注的进口注册证号经查并不存在；</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); 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%; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">二是其产品铭牌标签上未见产品使用期限或有效期、代理人等相关信息；</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); 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%; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">三是产品配件中的凸阵探头编号RAB4-8-D不在注册证附件清单内，属于未经注册的配件。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); 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%; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">四是安全标识不合格。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">在立即组织专家组赴企业仓库进行进一步调查，并通过联系该品牌生产商之后，深圳检验检疫局确认上述产品并非该品牌生产商制造，涉嫌假冒。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">目前，深圳检验检疫局已对该企业立案调查处理。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br /></p><p style="text-align: center; line-height: 1.75em;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhveqSeZxxGibNFds6OXDYKKTaYat9SwtvVN99enQeXJlafuxQHHiam7tWrIpM6DU17Plq7KibicXR3ic5Mg/0?wx_fmt=jpeg" data-ratio="0.75" data-w="480" /></p><p style="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);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">各地陆续排查</span></strong></p><p style="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);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">在接到国家质检总局的警示通报之后，江苏泰州检验检疫部门，近日对2013年以来进口超声诊断仪的相关单证和检验记录进行了审核，严防假冒和翻新超声诊断仪进口。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">泰州检验检疫局按照《商检法》及其实施条例、《医疗器械监督管理条例》等相关法律法规要求，认真审核了报检资料，重点审查是否涉及国家局警示通报所列品牌产品和黑名单中的供货商、收货人，对进口设备的包装、外观、规格型号、标志标识、配置等进行查验，结合安装调试，对设备的安全、卫生、性能等指标进行检验。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">河北邢台检验检疫局，最近也迅速对辖区2013年以来进口的超声诊断仪进行排查工作。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">他们通过调阅业务档案进行核查。经查，辖区进口超声诊断仪共3台，品牌分别是GE和东芝，进口国是奥地利、挪威、日本，均为全新设备，不存在翻新、假冒等问题。同时对用货单位进行走访调查。 </p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">甘肃天水出入境检验检疫局也在7月27日下发通知，要求天水、陇南的各医疗器械使用单位在进口医疗器械时对生产商及代理商要仔细进行核查，同时在设备验收时对生产日期、医疗器械注册号、铭牌等关键点重点关注，严防假冒翻新设备流入。 </p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">近期，天水局组织人员对辖区某进口医疗器械使用单位进行了回访，对其进口医疗器械进行了跟踪检查，这也是天水局首次开展进口医疗器械跟踪检查工作。</p><p style="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);"> </p><p style="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);">下一步，天水局还将对辖区内近3年来进口的所有医疗器械进行一次跟踪检查，通过现场查看设备、查阅使用维护记录、填写调查问卷表等形式了解进口医疗器械的质量安全状况，对使用过程中出现的质量问题积极帮助使用单位与供货单位交涉处理，同时对出现的共性问题及时向上级汇报。 </p><p><br /></p><p style="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="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 邮编：510507</span></p><p style="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 传真：020-8722 8623</span></p><p style="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="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="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="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="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="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="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="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="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="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 style="line-height: 1.75em;"><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 23:51:42