2018年第一个月，108起医械召回！

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                    <section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><strong></strong></section><p><span>医疗器械第一新媒体</span></p><p><span>分享最专业的医疗器械知识</span></p></section><section><section><section>关注</section></section></section></section><section powered-by="gulangu"><section><section></section></section></section><p><br  /></p><p>根据CFDA官网显示，2018年一月份，共有108起医疗器械召回！</p><p><br  /></p><p><strong>国内外巨头在列，罗氏3起二级</strong></p><p><br  /></p><p>召回涉及到西门子、飞利浦、通用、罗氏、迈瑞、恩普等国内外巨头。</p><p><br  /></p><p>西门子：3起，包括2起诊断产品（三级）和1起摄影设备（三级）；</p><p><br  /></p><p>飞利浦：2起，包括1起摄影设备（三级）和1起电子发射系统（三级）；</p><p><br  /></p><p>通用：1起，麻醉机（二级）；</p><p><br  /></p><p>罗氏：3起，免疫分析仪（二级）；</p><p><br  /></p><p>迈瑞：1起，测定试剂盒（三级）；</p><p><br  /></p><p>恩普：1起，多普勒超声系统（三级）</p><p><br  /></p><p>……</p><p><br  /></p><p><strong>6起因“抽检不及格”召回</strong></p><p><br  /></p><p>自2017年起，国家监管部门对医械企业的飞检力度明显加大。从飞检的细化程度以及对象数量都较往年明显提高。在一月份的召回数据显示，将近每6起召回中就有1起是因为“抽检不及格”，抽检不及格率为15%。</p><p><br  /></p><p><strong>医疗设备召回最多</strong></p><p><br  /></p><p>在108起召回中，设备型医械占了超过50个席位。其中数目最多的是治疗仪和制氧机等临床平台产品。另外，影像和放射系统也为数不少。</p><p><br  /></p><p><strong>附表，2018年1月医疗器械召回一览表</strong></p><p><br  /></p><table cellspacing="0" cellpadding="0" width="668"><tbody><tr><td width="38" nowrap="" height="18"><p><strong><span>序</span></strong></p></td><td width="76" nowrap="" height="18"><p><strong><span>生产厂家</span></strong></p></td><td width="72" nowrap="" height="18"><p><strong><span>产品名称</span></strong></p></td><td width="42" nowrap="" height="18"><p><strong><span>召回级别</span></strong></p></td><td width="66" nowrap="" height="18"><p><strong><span>召回原因</span></strong></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>1</span></p></td><td width="76" nowrap="" height="18"><p><span>石家庄康安医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>医用外科口罩</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>2</span></p></td><td width="76" nowrap="" height="18"><p><span>安徽金健桥医疗科技</span></p></td><td width="72" nowrap="" height="18"><p><span>乳腺治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>内部管理</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>3</span></p></td><td width="76" nowrap="" height="18"><p><span>贝克曼库尔特商贸（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>生化多项校准品</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>测试结果错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>4</span></p></td><td width="76" nowrap="" height="18"><p><span>德尔格医疗设备（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>麻醉机、麻醉系统</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>用户使用不当</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>5</span></p></td><td width="76" nowrap="" height="18"><p><span>恒嘉医疗器械贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>螺旋断层放射治疗系统、螺旋断层与径照放射治疗系统</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>用户使用不当</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>6</span></p></td><td width="76" nowrap="" height="18"><p><span>上海优福通医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>7</span></p></td><td width="76" nowrap="" height="18"><p><span>飞利浦（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>X</span><span>射线计算机断层摄影设备、X射线计算机体层摄影设备</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>紧固件扭转问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>8</span></p></td><td width="76" nowrap="" height="18"><p><span>珀金埃尔默医学诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>琥珀酰丙酮样本前处理液</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>试剂瓶（瓶塞）存在缺陷</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>9</span></p></td><td width="76" nowrap="" height="18"><p><span>迈柯唯（上海）医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>压力蒸汽灭菌器</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>10</span></p></td><td width="76" nowrap="" height="18"><p><span>梅里埃诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>革兰氏阳性细菌鉴定卡</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>测试结果错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>11</span></p></td><td width="76" nowrap="" height="18"><p><span>爱克发医疗系统设备(上海)</span></p></td><td width="72" nowrap="" height="18"><p><span>医用干式胶片</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>12</span></p></td><td width="76" nowrap="" height="18"><p><span>罗氏诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>全自动生化免疫分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品软件问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>13</span></p></td><td width="76" nowrap="" height="18"><p><span>恒嘉医疗器械贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>螺旋断层放射治疗系统、螺旋断层与径照放射治疗系统</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品系统问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>14</span></p></td><td width="76" nowrap="" height="18"><p><span>爱科来国际贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>葡萄糖检测试纸（酶法）</span></p></td><td width="42" nowrap="" height="18"><p><span>一级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品含量问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>15</span></p></td><td width="76" nowrap="" height="18"><p><span>迈柯唯（上海）医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>灭菌器</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>16</span></p></td><td width="76" nowrap="" height="18"><p><span>贝克曼库尔特商贸（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>全自动免疫分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品使用风险</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>17</span></p></td><td width="76" nowrap="" height="18"><p><span>库克（中国）医疗贸易</span></p></td><td width="72" nowrap="" height="18"><p><span>输卵管导管插入术器械</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品头端掉落</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>18</span></p></td><td width="76" nowrap="" height="18"><p><span>贝克曼库尔特商贸（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>自动尿液分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>测试结果错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>19</span></p></td><td width="76" nowrap="" height="18"><p><span>雅培贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>血液分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>数值显示问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>20</span></p></td><td width="76" nowrap="" height="18"><p><span>强生（上海）医疗器材</span></p></td><td width="72" nowrap="" height="18"><p><span>髋关节手术工具</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>部件的熔化及移除问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>21</span></p></td><td width="76" nowrap="" height="18"><p><span>罗氏诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>模块化生化免疫分析系统、全自动生化免疫分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品使用风险</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>22</span></p></td><td width="76" nowrap="" height="18"><p><span>飞利浦（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>X</span><span>射线计算机断层摄影设备、X射线计算机体层摄影设备</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>部件松动</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>23</span></p></td><td width="76" height="18"><p><span>罗氏诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>电化学发光全自动免疫分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品软件问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>24</span></p></td><td width="76" nowrap="" height="18"><p><span>康尔福盛（上海）商贸</span></p></td><td width="72" nowrap="" height="18"><p><span>注射泵</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>注射泵报警问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>25</span></p></td><td width="76" nowrap="" height="18"><p><span>贝克曼库尔特商贸（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>k</span><span>轻链检测试剂盒（免疫比浊法）</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品精密度不佳</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>26</span></p></td><td width="76" nowrap="" height="18"><p><span>天津泰康阳光科技</span></p></td><td width="72" nowrap="" height="18"><p><span>电动轮椅车</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>27</span></p></td><td width="76" nowrap="" height="18"><p><span>史赛克（北京）医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>冲洗吸引设备</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>说明书描述问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>28</span></p></td><td width="76" nowrap="" height="18"><p><span>贝克曼库尔特商贸（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>自动推片染片系统、血液分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>吸样问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>29</span></p></td><td width="76" nowrap="" height="18"><p><span>贝克曼库尔特商贸（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>尿液分析试纸条（干化学法）</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品生产错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>30</span></p></td><td width="76" nowrap="" height="18"><p><span>上海浦东金环医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>金属骨针</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>31</span></p></td><td width="76" nowrap="" height="18"><p><span>上海得邦得力激光技术</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>32</span></p></td><td width="76" nowrap="" height="18"><p><span>西门子医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>X</span><span>射线计算机体层摄影设备</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>紧固力矩不足</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>33</span></p></td><td width="76" nowrap="" height="18"><p><span>上海浦东金环医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>金属骨针</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>34</span></p></td><td width="76" nowrap="" height="18"><p><span>上海得邦得力激光技术</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>35</span></p></td><td width="76" nowrap="" height="18"><p><span>通用电气医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>麻醉机</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品硬件连接问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>36</span></p></td><td width="76" nowrap="" height="18"><p><span>飞利浦（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>正电子发射及X射线计算机断层成像系统</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品软件问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>37</span></p></td><td width="76" nowrap="" height="18"><p><span>史赛克（北京）医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>高真空骨水泥搅拌器/套管组件等产品</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品负载问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>38</span></p></td><td width="76" nowrap="" height="18"><p><span>长庚医疗科技（厦门）</span></p></td><td width="72" nowrap="" height="18"><p><span>电动病床</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>39</span></p></td><td width="76" nowrap="" height="18"><p><span>施乐辉医用产品国际贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>髋臼系统产品</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>40</span></p></td><td width="76" nowrap="" height="18"><p><span>强生视力健商贸（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>对软性角膜接触镜(商品名：舒日)</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>镜片变色</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>41</span></p></td><td width="76" nowrap="" height="18"><p><span>沈阳永林医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>永林综合治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>42</span></p></td><td width="76" nowrap="" height="18"><p><span>沈阳爱尔泰科技</span></p></td><td width="72" nowrap="" height="18"><p><span>医用分子筛制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>43</span></p></td><td width="76" nowrap="" height="18"><p><span>深圳市恩普电子技术</span></p></td><td width="72" nowrap="" height="18"><p><span>全数字彩色多普勒超声诊断系统</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>说明书描述问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>44</span></p></td><td width="76" nowrap="" height="18"><p><span>深圳迈瑞生物医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>对镁（Mg）测定试剂盒（二甲苯胺蓝法）</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>45</span></p></td><td width="76" nowrap="" height="18"><p><span>百赛国际贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>可吸收人工骨粉</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品申报问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>46</span></p></td><td width="76" nowrap="" height="18"><p><span>稳健医疗（黄冈）</span></p></td><td width="72" nowrap="" height="18"><p><span>一次性使用医用橡胶检查手套</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品与标识不符</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>47</span></p></td><td width="76" nowrap="" height="18"><p><span>厚福医疗装备</span></p></td><td width="72" nowrap="" height="18"><p><span>电动病床</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>48</span></p></td><td width="76" nowrap="" height="18"><p><span>上海汉莲医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>电动医用病床</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品材质问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>49</span></p></td><td width="76" nowrap="" height="18"><p><span>江苏富林医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>医用制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>50</span></p></td><td width="76" nowrap="" height="18"><p><span>强生（上海）医疗器材</span></p></td><td width="72" nowrap="" height="18"><p><span>医用皮肤组织胶</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>组织胶粘附问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>51</span></p></td><td width="76" nowrap="" height="18"><p><span>百赛国际贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>硫酸钙</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品注册问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>52</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北益健堂科技</span></p></td><td width="72" nowrap="" height="18"><p><span>电位治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>53</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉市康本龙医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>温热中低频治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>说明书项不符合标准要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>54</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北康达医药</span></p></td><td width="72" nowrap="" height="18"><p><span>光子嫩肤仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品能量输出问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>55</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北康达医药</span></p></td><td width="72" nowrap="" height="18"><p><span>二氧化碳激光治疗机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品输出值偏差问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>56</span></p></td><td width="76" nowrap="" height="18"><p><span>雅培贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>全自动生化分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品的底座脱离风险</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>57</span></p></td><td width="76" nowrap="" height="18"><p><span>皆美（上海）医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>种植体配套用工具、种植手术用牙钻及附件</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品的螺刀制造问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>58</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉市九头鸟医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>红蓝光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>59</span></p></td><td width="76" nowrap="" height="18"><p><span>奥林巴斯贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>内镜清洗消毒装置</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>说明书修改</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>60</span></p></td><td width="76" nowrap="" height="18"><p><span>西门子医学诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>全自动化学发光免疫分析仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>顶盖维护问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>61</span></p></td><td width="76" nowrap="" height="18"><p><span>库克（中国）医疗贸易</span></p></td><td width="72" nowrap="" height="18"><p><span>胚胎转移导管、输卵管内移植套装</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品试验问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>62</span></p></td><td width="76" nowrap="" height="18"><p><span>江苏富林医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>KD</span><span>系列低频治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>63</span></p></td><td width="76" nowrap="" height="18"><p><span>江苏富林医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>超声雾化器</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>64</span></p></td><td width="76" nowrap="" height="18"><p><span>康蒂思(上海)医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>镍钛支架系统</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>导管裂缝问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>65</span></p></td><td width="76" nowrap="" height="18"><p><span>德尔格医疗设备（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>呼吸机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标示错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>66</span></p></td><td width="76" nowrap="" height="18"><p><span>医科达（上海）医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>医用直线加速器</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>传感器、控制系统故障</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>67</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉奇致激光技术股份</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光脱毛仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>68</span></p></td><td width="76" nowrap="" height="18"><p><span>捷迈（上海）医疗国际贸易</span></p></td><td width="72" nowrap="" height="18"><p><span>全膝关节假体系统、膝关节假体-髌骨部件</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品包装问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>69</span></p></td><td width="76" nowrap="" height="18"><p><span>江苏富林医疗设备</span></p></td><td width="72" nowrap="" height="18"><p><span>超声雾化器</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>70</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉博激世纪科技</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>71</span></p></td><td width="76" nowrap="" height="18"><p><span>波科国际医疗贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>对植入式心脏再同步治疗除颤器、植入式心脏再同步治疗起搏器、植入式心脏起搏器</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>起搏错误</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>72</span></p></td><td width="76" nowrap="" height="18"><p><span>江苏富林医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>臂式电子血压计</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>说明书问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>73</span></p></td><td width="76" nowrap="" height="18"><p><span>爱德华（上海）医疗用品</span></p></td><td width="72" nowrap="" height="18"><p><span>静脉血管鞘</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品内径偏小</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>74</span></p></td><td width="76" height="18"><p><span>西门子医学诊断产品（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>糖类抗原15-3测定试剂盒（化学发光法）</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>检测结果偏差</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>75</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉康吉尔医疗科技</span></p></td><td width="72" nowrap="" height="18"><p><span>无创自动测量血压计</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>76</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉康喜科技</span></p></td><td width="72" nowrap="" height="18"><p><span>电位治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>77</span></p></td><td width="76" nowrap="" height="18"><p><span>奥林巴斯贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>电子输尿管肾盂镜、纤维输尿管肾盂镜</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>采用产品改进对象</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>78</span></p></td><td width="76" nowrap="" height="18"><p><span>赛默飞世尔（上海）仪器</span></p></td><td width="72" nowrap="" height="18"><p><span>冷冻切片机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>79</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉健康世家科技</span></p></td><td width="72" nowrap="" height="18"><p><span>医用制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>80</span></p></td><td width="76" nowrap="" height="18"><p><span>同科林医疗仪器（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品软件升级</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>81</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉市江北医疗保健器械</span></p></td><td width="72" nowrap="" height="18"><p><span>电动病床</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>82</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北康达医药</span></p></td><td width="72" nowrap="" height="18"><p><span>光子嫩肤仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>输出能量偏小</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>83</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉市九头鸟医疗仪器</span></p></td><td width="72" nowrap="" height="18"><p><span>红蓝光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>84</span></p></td><td width="76" nowrap="" height="18"><p><span>四川友邦企业</span></p></td><td width="72" nowrap="" height="18"><p><span>医用外科口罩</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>不符合技术要求</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>85</span></p></td><td width="76" nowrap="" height="18"><p><span>Hologic, Inc.</span></p></td><td width="72" nowrap="" height="18"><p><span>全自动核酸检测系统</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品面板分离</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>86</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉奇致激光技术</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光脱毛仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>87</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉康吉尔医疗科技</span></p></td><td width="72" nowrap="" height="18"><p><span>无创自动测量血压计</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>88</span></p></td><td width="76" nowrap="" height="18"><p><span>百赛国际贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>可吸收人工骨粉</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品注册问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>89</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉市康本龙医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>温热中低频治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>说明书问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>90</span></p></td><td width="76" nowrap="" height="18"><p><span>厚福医疗装备</span></p></td><td width="72" nowrap="" height="18"><p><span>电动病床</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>91</span></p></td><td width="76" nowrap="" height="18"><p><span>四川大爱科技</span></p></td><td width="72" nowrap="" height="18"><p><span>医用制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>92</span></p></td><td width="76" nowrap="" height="18"><p><span>江苏双盛医疗器械</span></p></td><td width="72" nowrap="" height="18"><p><span>制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>93</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北益健堂科技</span></p></td><td width="72" nowrap="" height="18"><p><span>电位治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>94</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉健康世家科技</span></p></td><td width="72" nowrap="" height="18"><p><span>医用制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>95</span></p></td><td width="76" nowrap="" height="18"><p><span>成都市卫生材料厂</span></p></td><td width="72" nowrap="" height="18"><p><span>医用外科口罩</span></p></td><td width="42" nowrap="" height="18"><p><span>不详</span></p></td><td width="66" nowrap="" height="18"><p><span>产品原材料问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>96</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉康喜科技</span></p></td><td width="72" nowrap="" height="18"><p><span>电位治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>97</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北康达医药</span></p></td><td width="72" nowrap="" height="18"><p><span>二氧化碳激光治疗机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>输出值偏差大</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>98</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉博激世纪科技</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>99</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉市江北医疗保健器械</span></p></td><td width="72" nowrap="" height="18"><p><span>电动病床</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>100</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉康吉尔医疗科技</span></p></td><td width="72" nowrap="" height="18"><p><span>无创自动测量血压计</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>101</span></p></td><td width="76" nowrap="" height="18"><p><span>四川大爱科技有限公司</span></p></td><td width="72" nowrap="" height="18"><p><span>医用制氧机</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>102</span></p></td><td width="76" nowrap="" height="18"><p><span>武汉博激世纪科技</span></p></td><td width="72" nowrap="" height="18"><p><span>半导体激光治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>103</span></p></td><td width="76" nowrap="" height="18"><p><span>湖北益健堂科技</span></p></td><td width="72" nowrap="" height="18"><p><span>电位治疗仪</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>抽检不合格</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>104</span></p></td><td width="76" nowrap="" height="18"><p><span>波科国际医疗贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>植入式起搏电极导线、植入式心脏起搏电极导线</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>电极导线问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>105</span></p></td><td width="76" nowrap="" height="18"><p><span>波科国际医疗贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>植入式心脏再同步治疗起搏器</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品标识问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>106</span></p></td><td width="76" nowrap="" height="18"><p><span>波科国际医疗贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>植入式心脏起搏电极导线</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>电极导线问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>107</span></p></td><td width="76" nowrap="" height="18"><p><span>捷迈（上海）医疗</span></p></td><td width="72" nowrap="" height="18"><p><span>肩关节系统</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>生产批号问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>108</span></p></td><td width="76" nowrap="" height="18"><p><span>施乐辉医用产品国际贸易（上海）</span></p></td><td width="72" nowrap="" height="18"><p><span>外固定系统</span></p></td><td width="42" nowrap="" height="18"><p><span>二级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品软件问题</span></p></td></tr><tr><td width="38" nowrap="" height="18"><p><span>109</span></p></td><td width="76" nowrap="" height="18"><p><span>　飞利浦（中国）</span></p></td><td width="72" nowrap="" height="18"><p><span>X</span><span>射线计算机体层摄影设备</span></p></td><td width="42" nowrap="" height="18"><p><span>三级</span></p></td><td width="66" nowrap="" height="18"><p><span>产品软件问题</span></p></td></tr></tbody></table><p><span><span><br  /></span></span></p><p><span>整理：赛柏蓝器械</span></p><p><span></span></p><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><p><span><strong>相关阅读</strong></span></p></section><p><p><img src="image/20201014/ec237188ae1e9c03eb4d9814f31b18ab_2.gif" 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