注意！这类射频消融设备、医用低温箱、手术刀片等医疗器械面临召回

admin

                    

                    

                    
                    
                    <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 data-style-type="5" data-tools="新媒体排版" data-id="114939"><section><section powered-by="gulangu"><section><section></section></section></section></section></section><p><br  /></p><p>2月14日，CFDA发布了2018年第2期国家医疗器械质量公告，公布了一批涉嫌违规的医疗器械：</p><p><br  /></p><p><p><img src="image/20201014/a6e6c59daaffbfb1fd5930cfc0e4d65b_2.png" /></p></p><p><br  /></p><p>抽检产品包括射频消融设备、医用低温箱、手术刀片等8个品种65批（台）的产品。抽检结果公告如下：</p><p><br  /></p><p>一、被抽检项目不符合标准规定的医疗器械产品，涉及3家企业的2个品种3批。具体为：</p><p><br  /></p><p>（一）一次性使用无菌阴道扩张器2家企业2批次产品。河南华林医疗器械有限公司生产的1批次一次性使用无菌阴道扩张器，抗变形能力、环氧乙烷残留量不符合标准规定；新乡市利群医疗器械有限公司生产的1批次一次性使用无菌阴道扩张器，抗变形能力不符合标准规定。</p><p><br  /></p><p>（二）手术衣1家企业1批次产品。河南省珠峰医疗器械有限公司生产的1批次一次性使用手术衣，阻微生物穿透，湿态（产品关键区域）、抗渗水性（产品关键区域）不符合标准规定。</p><p>　　</p><table cellspacing="0" cellpadding="0" width="974"><thead><tr><td width="57" height="32"><p><span>序号</span></p></td><td width="131" height="32"><p><span>标示产品名称</span></p></td><td width="123" height="32"><p><span>被抽查单位</span></p></td><td width="118" height="32"><p><span>标示生产企业</span></p></td><td width="93" height="32"><p><span>规格型号</span></p></td><td width="123" height="32"><p><span>生产日期</span><span>/</span><span>批号</span></p></td><td width="75" height="32"><p><span>抽样单位</span></p></td><td width="94" height="32"><p><span>检验单位</span></p></td><td width="123" height="32"><p><span>不符合标准规定项</span></p></td></tr></thead><tbody><tr><td width="57" height="55"><p><span>1</span></p></td><td width="131" height="55"><p><span>一次性使用无菌阴道扩张器</span></p></td><td width="123" height="55"><p><span>河南华林医疗器械有限公司</span></p></td><td width="118" height="55"><p><span>河南华林医疗器械有限公司</span></p></td><td width="93" height="55"><p><span>中号</span></p></td><td width="123" height="55"><p><span>2017</span><span>年</span><span>03</span><span>月</span><span>02</span><span>日</span><span>170302</span></p></td><td width="75" height="55"><p><span>河南省食品药品监督管理局</span></p></td><td width="94" height="55"><p><span>上海市医疗器械检测所</span></p></td><td width="123" height="55"><p><span>1.</span><span>抗变形能力</span><span>；</span><span>2.</span><span>环氧乙烷残留量</span></p></td></tr><tr><td width="57" height="55"><p><span>2</span></p></td><td width="131" height="55"><p><span>一次性使用无菌阴道扩张器</span></p></td><td width="123" height="55"><p><span>新乡市利群医疗器械有限公司</span></p></td><td width="118" height="55"><p><span>新乡市利群医疗器械有限公司</span></p></td><td width="93" height="55"><p><span>中号</span><span>A</span><span>半透明轴转式</span></p></td><td width="123" height="55"><p><span>170102</span></p></td><td width="75" height="55"><p><span>河南省食品药品监督管理局</span></p></td><td width="94" height="55"><p><span>上海市医疗器械检测所</span></p></td><td width="123" height="55"><p><span>抗变形能力</span></p></td></tr><tr><td width="57" height="55"><p><span>3</span></p></td><td width="131" height="55"><p><span>一次性使用手术衣</span></p></td><td width="123" height="55"><p><span>河南省珠峰医疗器械有限公司</span></p></td><td width="118" height="55"><p><span>河南省珠峰医疗器械有限公司</span></p></td><td width="93" height="55"><p><span>120×120cm </span><span>Ⅱ</span><span>型</span><span>加强</span></p><p><span>型</span><span>B</span></p></td><td width="123" height="55"><p><span>2016</span><span>年</span><span>05</span><span>月</span><span>21</span><span>日</span><span>160521SJ20000</span></p></td><td width="75" height="55"><p><span>河南省食品药品监督管理局</span></p></td><td width="94" height="55"><p><span>山东省医疗器械产品质量检验中心</span></p></td><td width="123" height="55"><p><span>1.</span><span>阻微生物穿透，湿态（产品关键区域）</span><span>；</span><span>2.</span><span>抗渗水性（产品关键区域）</span></p></td></tr></tbody></table><p><br  />二、被抽检项目为标识标签、说明书等项目不符合标准规定的医疗器械产品，涉及2家企业的1个品种2台，具体为：</p><p><br  /></p><p>医用氧气浓缩器（医用制氧机）2家企业2台产品。江苏双盛医疗器械有限公司生产的1台制氧机、陕西民起电子科技有限公司生产的1台医用制氧机，外部标记不符合标准规定。</p><p><br  /></p><table cellspacing="0" cellpadding="0" width="907"><thead><tr><td width="53" height="32"><p><span>序号</span></p></td><td width="104" height="32"><p><span>标示产品名称</span></p></td><td width="111" height="32"><p><span>被抽查单位</span></p></td><td width="108" height="32"><p><span>标示生产企业</span></p></td><td width="87" height="32"><p><span>规格型号</span></p></td><td width="117" height="32"><p><span>生产日期</span><span>/</span><span>批号</span><span>/</span></p><p><span>出厂编号</span></p></td><td width="103" height="32"><p><span>抽样单位</span></p></td><td width="94" height="32"><p><span>检验单位</span></p></td><td width="129" height="32"><p><span>不符合标准规定项</span></p></td></tr></thead><tbody><tr><td width="53" height="55"><p><span>1</span></p></td><td width="104" height="55"><p><span>制氧机　</span></p></td><td width="111" height="55"><p><span>贵州康尔乐科技发展有限公司</span></p></td><td width="108" height="55"><p><span>江苏双盛医疗器械有限公司</span></p></td><td width="87" height="55"><p><span>SS-3WB</span></p></td><td width="117" height="55"><p><span>20160623</span></p><p><span>160600001</span></p><p><span>160600149</span></p></td><td width="103" height="55"><p><span>贵州省食品药品监督管理局　</span></p></td><td width="94" height="55"><p><span>四川省医疗器械检测中心</span></p></td><td width="129" height="55"><p><span>外部标记</span></p></td></tr><tr><td width="53" height="55"><p><span>2</span></p></td><td width="104" height="55"><p><span>医用制氧机　</span></p></td><td width="111" height="55"><p><span>陕西民起电子科技有限公司</span></p></td><td width="108" height="55"><p><span>陕西民起电子科技有限公司</span></p></td><td width="87" height="55"><p><span>S3BPW</span></p></td><td width="117" height="55"><p><span>2017/04/25</span></p><p><span>20170406</span></p><p><span>AZ17Y040640</span></p></td><td width="103" height="55"><p><span>陕西省食品药品监督管理局　</span></p></td><td width="94" height="55"><p><span>四川省医疗器械检测中心</span></p></td><td width="129" height="55"><p><span>外部标记</span></p></td></tr></tbody></table><p><br  /></p><p>三、抽检项目全部符合标准规定的医疗器械产品涉及29家企业的5个品种60批（台）。</p><table cellspacing="0" cellpadding="0" width="929"><thead><tr><td width="44" height="32"><p><span>序号</span></p></td><td width="75" height="32"><p><span>标示产品名称</span></p></td><td width="134" height="32"><p><span>被抽查单位</span></p></td><td width="135" height="32"><p><span>标示生产企业</span></p></td><td width="106" height="32"><p><span>规格型号</span></p></td><td width="143" height="32"><p><span>生产日期</span><span>/</span><span>批号</span><span>/</span></p><p><span>出厂编号</span></p></td><td width="121" height="32"><p><span>抽样单位</span></p></td><td width="132" height="32"><p><span>检验单位</span></p></td></tr></thead><tbody><tr><td width="44" height="44"><p><span>1</span></p></td><td width="75" height="44"><p><span>心脏射频消融仪</span></p></td><td width="134" height="44"><p><span>四川锦江电子科技有限公司</span></p></td><td width="135" height="44"><p><span>四川锦江电子科技有限公司</span></p></td><td width="106" height="44"><p><span>VATION-100C</span></p></td><td width="143" height="44"><p><span>2016</span><span>年</span><span>11</span><span>月</span></p><p><span>XC161105</span></p></td><td width="121" height="44"><p><span>四川省食品药品监督管理局　</span></p></td><td width="132" height="44"><p><span>天津市医疗器械质量监督检验中心</span></p></td></tr><tr><td width="44" height="48"><p><span>2</span></p></td><td width="75" height="48"><p><span>全景口腔和头颅</span><span>X</span><span>射线成像系统</span></p></td><td width="134" height="48"><p><span>上海怡友医疗器械有限公司</span></p></td><td width="135" height="48"><p><span>上海怡友医疗器械有限公司</span></p></td><td width="106" height="48"><p><span>aX-400C</span></p></td><td width="143" height="48"><p><span>2017-03</span></p><p><span>088-0960</span></p></td><td width="121" height="48"><p><span>四川省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>天津市医疗器械质量监督检验中心</span></p></td></tr><tr><td width="44" height="50"><p><span>3</span></p></td><td width="75" height="50"><p><span>数字口腔颌面全景</span><span>X</span><span>射线机</span></p></td><td width="134" height="50"><p><span>福建梅生医疗科技股份有限公司</span></p></td><td width="135" height="50"><p><span>福建梅生医疗科技股份有限公司</span></p></td><td width="106" height="50"><p><span>MSQS2009-I</span></p></td><td width="143" height="50"><p><span>2017</span><span>年</span><span>5</span><span>月</span><span>13</span><span>日</span><span>3062/3062</span></p></td><td width="121" height="50"><p><span>上海市食品药品监督管理局</span></p></td><td width="132" height="50"><p><span>广东省医疗器械质量监督检验所</span></p></td></tr><tr><td width="44" height="48"><p><span>4</span></p></td><td width="75" height="48"><p><span>口腔颌面全景</span><span>X</span><span>射线机</span></p></td><td width="134" height="48"><p><span>西诺德牙科设备商贸（上海）有限公司</span></p></td><td width="135" height="48"><p><span>Sirona</span><span> Dental &nbsp;Systems GmbH</span></p></td><td width="106" height="48"><p><span>ORTHOPHOS XG 3</span></p></td><td width="143" height="48"><p><span>2016-07-22</span></p><p><span>112564</span></p></td><td width="121" height="48"><p><span>福建省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>广东省医疗器械质量监督检验所</span></p></td></tr><tr><td width="44" height="105"><p><span>5</span></p></td><td width="75" height="105"><p><span>数字化医用</span><span>X</span><span>射线摄影系统</span></p></td><td width="134" height="105"><p><span>上海联影医疗科技有限公司</span></p></td><td width="135" height="105"><p><span>委托生产企业：上海联影医疗科技有限公司；受托生产企业：联影（常州）医疗科技有限公司</span></p></td><td width="106" height="105"><p><span>uDR</span><span> 588h</span></p></td><td width="143" height="105"><p><span>2017</span><span>年</span><span>1</span><span>月</span><span>21</span><span>日</span></p><p><span>252170</span></p></td><td width="121" height="105"><p><span>上海市食品药品监督管理局</span></p></td><td width="132" height="105"><p><span>广东省医疗器械质量监督检验所</span></p></td></tr><tr><td width="44" height="57"><p><span>6</span></p></td><td width="75" height="57"><p><span>数字高频医用诊断</span><span>X</span><span>射线机</span></p></td><td width="134" height="57"><p><span>重庆华伦医疗器械有限公司</span></p></td><td width="135" height="57"><p><span>重庆华伦医疗器械有限公司</span></p></td><td width="106" height="57"><p><span>HLDR-50P</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>05</span><span>月</span></p><p><span>G1705001</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局</span></p></td><td width="132" height="57"><p><span>北京市医疗器械检验所</span></p></td></tr><tr><td width="44" height="57"><p><span>7</span></p></td><td width="75" height="57"><p><span>数字化医用</span><span>X</span><span>射线摄影系统</span></p></td><td width="134" height="57"><p><span>上海中科再启医疗设备有限公司</span></p></td><td width="135" height="57"><p><span>上海中科再启医疗设备有限公司</span></p></td><td width="106" height="57"><p><span>NeatDR</span><span> G50</span></p></td><td width="143" height="57"><p><span>2017.05</span></p><p><span>17X11705002</span></p></td><td width="121" height="57"><p><span>重庆市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>北京市医疗器械检验所</span></p></td></tr><tr><td width="44" height="57"><p><span>8</span></p></td><td width="75" height="57"><p><span>数字化医用</span><span>X</span><span>射线摄影系统</span></p></td><td width="134" height="57"><p><span>安徽美时影像技术有限公司</span></p></td><td width="135" height="57"><p><span>安徽美时影像技术有限公司</span></p></td><td width="106" height="57"><p><span>型号：</span><span>TMDR-C1</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>5</span><span>月</span></p><p><span>TMDR-C1-0007</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局</span></p></td><td width="132" height="57"><p><span>北京市医疗器械检验所</span></p></td></tr><tr><td width="44" height="57"><p><span>9</span></p></td><td width="75" height="57"><p><span>数字</span><span>X</span><span>射线机</span></p></td><td width="134" height="57"><p><span>深圳市艾克瑞电气有限公司</span></p></td><td width="135" height="57"><p><span>深圳市艾克瑞电气有限公司</span></p></td><td width="106" height="57"><p><span>AKHX-50F</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>5</span><span>月</span></p><p><span>17041012</span></p></td><td width="121" height="57"><p><span>安徽省食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>上海市医疗器械检测所</span></p></td></tr><tr><td width="44" height="57"><p><span>10</span></p></td><td width="75" height="57"><p><span>数字化医用</span><span>X</span><span>射线摄影系统</span></p></td><td width="134" height="57"><p><span>南宁一举医疗电子设备股份有限公司</span></p></td><td width="135" height="57"><p><span>南宁一举医疗电子设备股份有限公司</span></p></td><td width="106" height="57"><p><span>YJF32DR-A</span></p></td><td width="143" height="57"><p><span>2017.05</span></p><p><span>F32DRA42A4</span></p></td><td width="121" height="57"><p><span>广东省食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>上海市医疗器械检测所</span></p></td></tr><tr><td width="44" height="48"><p><span>11</span></p></td><td width="75" height="48"><p><span>数字化医用</span><span>X</span><span>射线摄影系统</span></p></td><td width="134" height="48"><p><span>浏阳万力森医疗设备有限公司</span></p></td><td width="135" height="48"><p><span>浏阳万力森医疗设备有限公司</span></p></td><td width="106" height="48"><p><span>ICKE1600 DR</span></p></td><td width="143" height="48"><p><span>2017</span><span>年</span><span>04</span><span>月</span></p><p><span>17P04007</span></p></td><td width="121" height="48"><p><span>广西壮族自治区食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>上海市医疗器械检测所</span></p></td></tr><tr><td width="44" height="55"><p><span>12</span></p></td><td width="75" height="55"><p><span>数字化医用</span><span>X</span><span>射线摄影系统</span></p></td><td width="134" height="55"><p><span>广州市显浩医疗设备股份有限公司</span></p></td><td width="135" height="55"><p><span>广州市显浩医疗设备股份有限公司</span></p></td><td width="106" height="55"><p><span>XH68-III</span></p></td><td width="143" height="55"><p><span>2017</span><span>年</span><span>5</span><span>月</span><span>10</span><span>日</span></p><p><span>XH450008</span></p></td><td width="121" height="55"><p><span>湖南省食品药品监督管理局　</span></p></td><td width="132" height="55"><p><span>上海市医疗器械检测所</span></p></td></tr><tr><td width="44" height="66"><p><span>13</span></p></td><td width="75" height="66"><p><span>医用低温冰箱（</span><span>Biomedical &nbsp;freezer</span><span>）</span></p></td><td width="134" height="66"><p><span>松下健康医疗器械（上海）有限公司</span></p></td><td width="135" height="66"><p><span>松下健康医疗器械株式会社</span></p></td><td width="106" height="66"><p><span>MDF-U5412N</span></p></td><td width="143" height="66"><p><span>2016</span><span>年</span><span>12</span><span>月</span></p><p><span>16120359</span></p></td><td width="121" height="66"><p><span>广东省食品药品监督管理局　</span></p></td><td width="132" height="66"><p><span>上海市医疗器械检测所</span></p></td></tr><tr><td width="44" height="58"><p><span>14</span></p></td><td width="75" height="58"><p><span>医用低温冰箱</span></p></td><td width="134" height="58"><p><span>海信容声（广东）冷柜有限公司</span></p></td><td width="135" height="58"><p><span>海信容声（广东）冷柜有限公司</span></p></td><td width="106" height="58"><p><span>HD-40W260</span></p></td><td width="143" height="58"><p><span>2016-05-02</span></p><p><span>L-H28H</span></p></td><td width="121" height="58"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="58"><p><span>安徽省食品药品检验研究院</span></p></td></tr><tr><td width="44" height="48"><p><span>15</span></p></td><td width="75" height="48"><p><span>低温保存箱</span></p></td><td width="134" height="48"><p><span>赛默飞世尔科技（中国）有限公司</span></p></td><td width="135" height="48"><p><span>Thermo Fisher &nbsp;Scientific </span><span>（</span><span>Asheville</span><span>）</span><span> LLC</span></p></td><td width="106" height="48"><p><span>994</span></p></td><td width="143" height="48"><p><span>2017/02</span></p><p><span>300127336</span></p></td><td width="121" height="48"><p><span>广东省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>安徽省食品药品检验研究院</span></p></td></tr><tr><td width="44" height="48"><p><span>16</span></p></td><td width="75" height="48"><p><span>超低温保存箱</span></p></td><td width="134" height="48"><p><span>浙江爱雪制冷电器有限公司</span></p></td><td width="135" height="48"><p><span>浙江爱雪制冷电器有限公司</span></p></td><td width="106" height="48"><p><span>DW-40L270</span></p></td><td width="143" height="48"><p><span>ISR2016c090238016842</span></p></td><td width="121" height="48"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>安徽省食品药品检验研究院</span></p></td></tr><tr><td width="44" height="48"><p><span>17</span></p></td><td width="75" height="48"><p><span>医用低温保存箱</span></p></td><td width="134" height="48"><p><span>安徽中科都菱商用电器股份有限公司</span></p></td><td width="135" height="48"><p><span>安徽中科都菱商用电器股份有限公司</span></p></td><td width="106" height="48"><p><span>MDF-25H130</span></p></td><td width="143" height="48"><p><span>2017</span><span>年</span><span>4</span><span>月</span><span>1701000104MDF-25H130</span></p></td><td width="121" height="48"><p><span>浙江省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>安徽省食品药品检验研究院</span></p></td></tr><tr><td width="44" height="48"><p><span>18</span></p></td><td width="75" height="48"><p><span>医用低温箱</span></p></td><td width="134" height="48"><p><span>中科美菱低温科技股份有限公司</span></p></td><td width="135" height="48"><p><span>中科美菱低温科技股份有限公司</span></p></td><td width="106" height="48"><p><span>DW-YW166A</span></p></td><td width="143" height="48"><p><span>2017</span><span>年</span><span>05</span><span>月</span></p><p><span>170530495</span></p></td><td width="121" height="48"><p><span>安徽省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>山东省医疗器械产品质量检验中心</span></p></td></tr><tr><td width="44" height="48"><p><span>19</span></p></td><td width="75" height="48"><p><span>医用低温箱</span></p></td><td width="134" height="48"><p><span>松下冷链（大连）有限公司</span></p></td><td width="135" height="48"><p><span>松下冷链（大连）有限公司</span></p></td><td width="106" height="48"><p><span>SDF-C430</span></p></td><td width="143" height="48"><p><span>1780001</span></p></td><td width="121" height="48"><p><span>安徽省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>山东省医疗器械产品质量检验中心</span></p></td></tr><tr><td width="44" height="48"><p><span>20</span></p></td><td width="75" height="48"><p><span>手术刀片</span></p></td><td width="134" height="48"><p><span>上海弼晨医疗器械有限公司</span></p></td><td width="135" height="48"><p><span>上海弼晨医疗器械有限公司</span></p></td><td width="106" height="48"><p><span>11</span></p></td><td width="143" height="48"><p><span>2017</span><span>年</span><span>04</span><span>月</span><span>07</span><span>日</span></p><p><span>170408</span></p></td><td width="121" height="48"><p><span>辽宁省食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>山东省医疗器械产品质量检验中心</span></p></td></tr><tr><td width="44" height="48"><p><span>21</span></p></td><td width="75" height="48"><p><span>手术刀片</span></p></td><td width="134" height="48"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="135" height="48"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="106" height="48"><p><span>21#</span></p></td><td width="143" height="48"><p><span>2016</span><span>年</span><span>2</span><span>月</span><span>10</span><span>日</span></p><p><span>YHH-029</span></p></td><td width="121" height="48"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="48"><p><span>22</span></p></td><td width="75" height="48"><p><span>手术刀片</span></p></td><td width="134" height="48"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="135" height="48"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="106" height="48"><p><span>23#</span></p></td><td width="143" height="48"><p><span>2017</span><span>年</span><span>1</span><span>月</span><span>16</span><span>日</span></p><p><span>YHH-040</span></p></td><td width="121" height="48"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>23</span></p></td><td width="75" height="57"><p><span>手术刀片</span></p></td><td width="134" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>23/</span><span>无</span></p></td><td width="143" height="57"><p><span>20170402</span></p><p><span>31T0401</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>24</span></p></td><td width="75" height="57"><p><span>手术刀片</span></p></td><td width="134" height="57"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="135" height="57"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="57"><p><span>11</span><span>号</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>4</span><span>月</span><span>25</span><span>日</span></p><p><span>1S0406</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>25</span></p></td><td width="75" height="57"><p><span>手术刀片</span></p></td><td width="134" height="57"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="135" height="57"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="106" height="57"><p><span>11#</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>3</span><span>月</span><span>11</span><span>日</span></p><p><span>YHH-041</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>26</span></p></td><td width="75" height="57"><p><span>手术刀片</span></p></td><td width="134" height="57"><p><span>复旦大学附属中山医院</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>15</span></p></td><td width="143" height="57"><p><span>20141203</span></p><p><span>31Q1201</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="48"><p><span>27</span></p></td><td width="75" height="48"><p><span>手术刀片</span></p></td><td width="134" height="48"><p><span>上海医疗器械（集团）有限公司手术器械厂</span></p></td><td width="135" height="48"><p><span>上海医疗器械（集团）有限公司手术器械厂</span></p></td><td width="106" height="48"><p><span>11#</span></p></td><td width="143" height="48"><p><span>170303</span></p><p><span>002017</span></p></td><td width="121" height="48"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="48"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>28</span></p></td><td width="75" height="57"><p><span>无菌塑柄手术刀</span></p></td><td width="134" height="57"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="135" height="57"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="57"><p><span>11</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>3</span><span>月</span><span>6</span><span>日</span></p><p><span>3S0301</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>29</span></p></td><td width="75" height="57"><p><span>无菌手术刀片</span></p></td><td width="134" height="57"><p><span>复旦大学附属华山医院</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>21</span></p></td><td width="143" height="57"><p><span>20160907</span></p><p><span>35S0904</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>30</span></p></td><td width="75" height="57"><p><span>无菌手术刀片</span></p></td><td width="134" height="57"><p><span>上海市中西医结合医院</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>21</span></p></td><td width="143" height="57"><p><span>20160907</span></p><p><span>35S0907</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>31</span></p></td><td width="75" height="57"><p><span>无菌手术刀片</span></p></td><td width="134" height="57"><p><span>上海沪江医疗器材有限公司</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>11</span></p></td><td width="143" height="57"><p><span>20160910</span></p><p><span>35S0965</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>32</span></p></td><td width="75" height="57"><p><span>一次性使用无菌手术刀片</span></p></td><td width="134" height="57"><p><span>上海医用缝合针厂有限公司</span></p></td><td width="135" height="57"><p><span>上海医用缝合针厂有限公司</span></p></td><td width="106" height="57"><p><span>23</span><span>号</span></p></td><td width="143" height="57"><p><span>2017</span><span>年</span><span>3</span><span>月</span></p><p><span>D-080317</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>33</span></p></td><td width="75" height="57"><p><span>无菌手术刀片</span></p></td><td width="134" height="57"><p><span>上海市松江区中心医院</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>22</span></p></td><td width="143" height="57"><p><span>20160907</span></p><p><span>35S0912</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>34</span></p></td><td width="75" height="57"><p><span>无菌手术刀片</span></p></td><td width="134" height="57"><p><span>上海医疗器械（上海）有限公司</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>12</span></p></td><td width="143" height="57"><p><span>20160907</span></p><p><span>35S0905</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="57"><p><span>35</span></p></td><td width="75" height="57"><p><span>无菌手术刀片</span></p></td><td width="134" height="57"><p><span>上海新视界眼科一眼</span></p></td><td width="135" height="57"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="57"><p><span>15</span></p></td><td width="143" height="57"><p><span>20150907</span></p><p><span>35R0901</span></p></td><td width="121" height="57"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="57"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="91"><p><span>36</span></p></td><td width="75" height="91"><p><span>手术刀片</span></p></td><td width="134" height="91"><p><span>上海医疗器械（集团）有限公司手术器械厂</span></p></td><td width="135" height="91"><p><span>上海医疗器械（集团）有限公司手术器械厂</span></p></td><td width="106" height="91"><p><span>23#</span></p></td><td width="143" height="91"><p><span>170405</span></p><p><span>002017</span></p></td><td width="121" height="91"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="91"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="93"><p><span>37</span></p></td><td width="75" height="93"><p><span>无菌手术刀片</span></p></td><td width="134" height="93"><p><span>国药控股菱商医院管理服务（上海）有限公司</span></p></td><td width="135" height="93"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="93"><p><span>15</span></p></td><td width="143" height="93"><p><span>20160914</span></p><p><span>35S0925</span></p></td><td width="121" height="93"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="93"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="60"><p><span>38</span></p></td><td width="75" height="60"><p><span>无菌手术刀片</span></p></td><td width="134" height="60"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="135" height="60"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="60"><p><span>11/</span><span>无</span></p></td><td width="143" height="60"><p><span>20160919</span></p><p><span>35S0990</span></p></td><td width="121" height="60"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="60"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="60"><p><span>39</span></p></td><td width="75" height="60"><p><span>无菌手术刀片</span></p></td><td width="134" height="60"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="135" height="60"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="60"><p><span>11</span></p></td><td width="143" height="60"><p><span>2017.04.06</span></p><p><span>2S0401</span></p></td><td width="121" height="60"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="60"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="67"><p><span>40</span></p></td><td width="75" height="67"><p><span>无菌手术刀片</span></p></td><td width="134" height="67"><p><span>国药控股菱商医院管理服务（上海）有限公司</span></p></td><td width="135" height="67"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="67"><p><span>15</span></p></td><td width="143" height="67"><p><span>20160916</span></p><p><span>35S0927</span></p></td><td width="121" height="67"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="67"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="64"><p><span>41</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>国药集团上海医疗器械有限公司</span></p></td><td width="135" height="64"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="64"><p><span>21</span></p></td><td width="143" height="64"><p><span>20160907</span></p><p><span>35s0904</span></p></td><td width="121" height="64"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="64"><p><span>42</span></p></td><td width="75" height="64"><p><span>无菌塑柄手术刀</span></p></td><td width="134" height="64"><p><span>河南华林医疗器械有限公司</span></p></td><td width="135" height="64"><p><span>河南华林医疗器械有限公司</span></p></td><td width="106" height="64"><p><span>HL-23#</span></p></td><td width="143" height="64"><p><span>2017</span><span>年</span><span>01</span><span>月</span><span>13</span><span>日</span></p><p><span>170113</span></p></td><td width="121" height="64"><p><span>上海市食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>浙江省医疗器械检验院</span></p></td></tr><tr><td width="44" height="64"><p><span>43</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>濮阳市第三人民医院</span></p></td><td width="135" height="64"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="64"><p><span>11</span></p></td><td width="143" height="64"><p><span>2017.2.8</span></p><p><span>2S0201</span></p></td><td width="121" height="64"><p><span>河南省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>44</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>国药控股平顶山有限公司</span></p></td><td width="135" height="64"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="64"><p><span>11</span></p></td><td width="143" height="64"><p><span>2016.12.15</span></p><p><span>2R1203</span></p></td><td width="121" height="64"><p><span>河南省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>45</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>西双版纳宇辰经贸有限公司</span></p></td><td width="135" height="64"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="64"><p><span>20</span></p></td><td width="143" height="64"><p><span>2016.12.20</span></p><p><span>2R1204</span></p></td><td width="121" height="64"><p><span>河南省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>46</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>枞阳县人民医院</span></p></td><td width="135" height="64"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="64"><p><span>24</span></p></td><td width="143" height="64"><p><span>2015.11.10</span></p><p><span>2Q1101</span></p></td><td width="121" height="64"><p><span>云南省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>47</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>池州市国立大药房连锁有限公司</span></p></td><td width="135" height="64"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="64"><p><span>15</span></p></td><td width="143" height="64"><p><span>160917</span></p><p><span>35S0929</span></p></td><td width="121" height="64"><p><span>安徽省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>48</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>芒市创伤骨科医院</span></p></td><td width="135" height="64"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="64"><p><span>11</span></p></td><td width="143" height="64"><p><span>160923</span></p><p><span>35S0904</span></p></td><td width="121" height="64"><p><span>安徽省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>49</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>陕西华杰医疗器械有限公司</span></p></td><td width="135" height="64"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="64"><p><span>20</span></p></td><td width="143" height="64"><p><span>160910</span></p><p><span>35S0916</span></p></td><td width="121" height="64"><p><span>云南省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>50</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>西安交通大学第一附属医院</span></p></td><td width="135" height="64"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="64"><p><span>22</span></p></td><td width="143" height="64"><p><span>160913</span></p><p><span>35S0919</span></p></td><td width="121" height="64"><p><span>陕西省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="64"><p><span>51</span></p></td><td width="75" height="64"><p><span>无菌手术刀片</span></p></td><td width="134" height="64"><p><span>河北华北石油商业有限公司</span></p></td><td width="135" height="64"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="64"><p><span>23</span></p></td><td width="143" height="64"><p><span>160910</span></p><p><span>35S0933</span></p></td><td width="121" height="64"><p><span>陕西省食品药品监督管理局　</span></p></td><td width="132" height="64"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="72"><p><span>52</span></p></td><td width="75" height="72"><p><span>无菌手术刀片</span></p></td><td width="134" height="72"><p><span>黄石市国威医疗器械有限公司</span></p></td><td width="135" height="72"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="72"><p><span>23</span></p></td><td width="143" height="72"><p><span>160906</span></p><p><span>35S0917</span></p></td><td width="121" height="72"><p><span>河北省食品药品监督管理局　</span></p></td><td width="132" height="72"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="72"><p><span>53</span></p></td><td width="75" height="72"><p><span>一次性使用手术刀片</span></p></td><td width="134" height="72"><p><span>十堰市人民医院</span></p></td><td width="135" height="72"><p><span>杭州华威医疗用品有限公司</span></p></td><td width="106" height="72"><p><span>22</span></p></td><td width="143" height="72"><p><span>20170301</span></p><p><span>20170301</span></p></td><td width="121" height="72"><p><span>湖北省食品药品监督管理局　</span></p></td><td width="132" height="72"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="72"><p><span>54</span></p></td><td width="75" height="72"><p><span>无菌手术刀片</span></p></td><td width="134" height="72"><p><span>唐山市工人医院</span></p></td><td width="135" height="72"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="72"><p><span>23</span></p></td><td width="143" height="72"><p><span>160912</span></p><p><span>35S0940</span></p></td><td width="121" height="72"><p><span>湖北省食品药品监督管理局　</span></p></td><td width="132" height="72"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="72"><p><span>55</span></p></td><td width="75" height="72"><p><span>无菌手术刀片</span></p></td><td width="134" height="72"><p><span>内蒙古自治区人民医院</span></p></td><td width="135" height="72"><p><span>上海浦东金环医疗用品股份有限公司</span></p></td><td width="106" height="72"><p><span>12</span></p></td><td width="143" height="72"><p><span>160810</span></p><p><span>35S0801</span></p></td><td width="121" height="72"><p><span>河北省食品药品监督管理局　</span></p></td><td width="132" height="72"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="91"><p><span>56</span></p></td><td width="75" height="91"><p><span>无菌手术刀片</span></p></td><td width="134" height="91"><p><span>呼和浩特市永利达医疗器械有限责任公司</span></p></td><td width="135" height="91"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="91"><p><span>12</span></p></td><td width="143" height="91"><p><span>2016.11.08</span></p><p><span>2R1102</span></p></td><td width="121" height="91"><p><span>内蒙古自治区食品药品监督管理局　</span></p></td><td width="132" height="91"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="76"><p><span>57</span></p></td><td width="75" height="76"><p><span>手术刀片</span></p></td><td width="134" height="76"><p><span>山西益康弘科贸有限公司</span></p></td><td width="135" height="76"><p><span>上海联辉医疗用品有限公司</span></p></td><td width="106" height="76"><p><span>15</span></p></td><td width="143" height="76"><p><span>2016</span><span>年</span><span>8</span><span>月</span><span>9</span><span>日</span></p><p><span>1R0803</span></p></td><td width="121" height="76"><p><span>内蒙古自治区食品药品监督管理局　</span></p></td><td width="132" height="76"><p><span>山西省医疗器械检测中心</span></p></td></tr><tr><td width="44" height="77"><p><span>58</span></p></td><td width="75" height="77"><p><span>医用手术刀片</span></p></td><td width="134" height="77"><p><span>四平益邦医药有限公司</span></p></td><td width="135" height="77"><p><span>上海成元医疗用品厂</span></p></td><td width="106" height="77"><p><span>10</span><span>片装</span><span>/</span><span>包，</span></p><p><span>23</span><span>号</span></p></td><td width="143" height="77"><p><span>161002</span></p></td><td width="121" height="77"><p><span>山西省食品药品监督管理局　</span></p></td><td width="132" height="77"><p><span>内蒙古自治区药品检验研究院</span></p></td></tr><tr><td width="44" height="129"><p><span>59</span></p></td><td width="75" height="129"><p><span>一次性无菌手术刀片</span></p></td><td width="134" height="129"><p><span>山东福瑞达医药集团公司</span></p></td><td width="135" height="129"><p><span>生产商：</span><span>TECHNOLAS &nbspERFECT VISION GMBH </span><span>进口商：山东福瑞达医药集团公司</span></p></td><td width="106" height="129"><p><span>Accuglide</span></p></td><td width="143" height="129"><p><span>144668</span></p></td><td width="121" height="129"><p><span>吉林省食品药品监督管理局</span></p></td><td width="132" height="129"><p><span>内蒙古自治区药品检验研究院</span></p></td></tr><tr><td width="44" height="93"><p><span>60</span></p></td><td width="75" height="93"><p><span>手术刀片</span></p></td><td width="134" height="93"><p><span>哈尔滨远大民生医疗器械有限公司</span></p></td><td width="135" height="93"><p><span>上海元洪医疗器械有限公司</span></p></td><td width="106" height="93"><p><span>10</span></p></td><td width="143" height="93"><p><span>2015</span><span>年</span><span>9</span><span>月</span><span>23</span><span>日</span></p><p><span>YHH-024</span></p></td><td width="121" height="93"><p><span>山东省食品药品监督管理局</span></p></td><td width="132" height="93"><p><span>内蒙古自治区药品检验研究院</span></p></td></tr></tbody></table><p><br  /></p><p>相关企业应对抽检不符合标准规定的产品进行风险评估，根据医疗器械缺陷的严重程度确定召回级别，主动召回产品并公开召回信息。同时，应尽快查明产品不合格原因，制定整改措施并按期整改到位，有关处置情况于2018年3月10日前向社会公布，并及时将相关情况报告至所在地省级食品药品监督管理部门。</p><p><br  /></p><p>对上述抽检中发现的不符合标准规定产品，国家食品药品监督管理总局已要求企业所在地省级食品药品监督管理部门按照《医疗器械监督管理条例》及《食品药品监管总局办公厅关于进一步加强医疗器械抽验工作的通知》（食药监办械监〔2016〕9号）的要求，对相关企业进行调查处理，监督企业进行产品召回、不合格原因调查、整改措施及公开披露信息的落实情况；产品对人体造成伤害或者有证据证明可能危害人体健康的，应依法采取暂停生产、经营、使用的紧急控制措施；需要暂停进口的，应及时报总局做出行政处理决定。企业未按要求落实上述要求的，所在地省级食品药品监督管理部门要依法严肃查处。</p><p>　　　　</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_3.gif" /></p><span>多起医疗设备召回，PET-CT、CT……纷纷“中招”</span></p><p><br  /></p><p><span>【重磅】新版医疗器械召回管理办法发布+官方解读</span></p><p><br  /></p><p><span>【深度解析】医疗器械不良事件和召回解析</span></p></section></section><p><br  /></p></section></section></section></section></section></section></section></section></section><p><p><img src="image/20201014/ddc723b50bcaa3c373cb35a0033daacd_4.jpg" /></p></p>