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飞利浦关于除颤仪主动召回的公


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飞利浦已就其生产的HeartStart XL除颤仪产品在电源电路板上的内部元器件可能会发生故障而潜在影响到器械的治疗性能的问题,主动进行召回。根据《医疗器械召回管理办法(试行)》(卫生部令第82号)的相关规定,截止至目前飞利浦中国(投资)有限公司已经完成境内受影响的2748台HeartStart XL除颤仪的现场改进措施,消除了潜在风险,并获得客户的认可。目前我们发现还有部分设备不能在客户现场找到,可能是因为购买时间较长或已经淘汰使用。为了保证此次主动召回的所有受影响设备不被遗漏,我们特将这些无法定位到的设备序列号在网上公布。

  如您在使用以下序列号的HeartStart XL除颤仪,请您在2017年2 月12日前致电800-810-0038/ 400-810-0038免费服务热线(7*24小时),或者直接联系您所在区域的经销商或飞利浦销售代表。飞利浦将会在核实信息后,尽快为您的设备实施免费的现场改进纠正措施。

  以下242台受影响设备未能追踪到最终用户,其序列号如下表所示:

US00603455 | US00604776 | US00606096 | US00606260 | US00606381  US00603456 | US00604777 | US00606097 | US00606261 | US00606484  US00603457 | US00604778 | US00606102 | US00606262 | US00606536  US00603459 | US00604780 | US00606103 | US00606263 | US00606537  US00603461 | US00604781 | US00606104 | US00606264 | US00606538  US00603462 | US00604782 | US00606105 | US00606265 | US00606539  US00603463 | US00604783 | US00606106 | US00606309 | US00606541  US00603464 | US00604784 | US00606107 | US00606311 | US00606542  US00603465 | US00604785 | US00606108 | US00606313 | US00607395  US00603466 | US00604786 | US00606109 | US00606314 | US00607830  US00603467 | US00604787 | US00606110 | US00606315 | US00607831  US00603468 | US00604788 | US00606111 | US00606316 | US00585842  US00603469 | US00604789 | US00606112 | US00606317 | US00600050  US00603471 | US00604790 | US00606113 | US00606324 | US00603230  US00603473 | US00604791 | US00606189 | US00606325 | US00603231  US00603474 | US00604792 | US00606190 | US00606328 | US00603233  US00603475 | US00604793 | US00606192 | US00606330 | US00603263  US00603478 | US00604794 | US00606194 | US00606331 | US00603264  US00603480 | US00604795 | US00606195 | US00606332 | US00603304  US00603481 | US00604796 | US00606196 | US00606333 | US00603359  US00603482 | US00604797 | US00606197 | US00606335 | US00603489  US00603483 | US00604798 | US00606198 | US00606336 | US00604704  US00603791 | US00604800 | US00606199 | US00606337 | US00604705  US00603792 | US00604801 | US00606200 | US00606338 | US00604706  US00604296 | US00604802 | US00606203 | US00606339 | US00604707  US00604382 | US00604803 | US00606251 | US00606340 | US00604709  US00604398 | US00604804 | US00606252 | US00606341 | US00604710  US00604404 | US00604805 | US00606253 | US00606342 | US00604711  US00604471 | US00604806 | US00606254 | US00606376 | US00604712  US00604584 | US00604807 | US00606255 | US00606377 | US00605241  US00604672 | US00604808 | US00606256 | US00606378 | US00605257  US00604774 | US00606094 | US00606257 | US00606379 | US00606183  US00604775 | US00606095 | US00606259 | US00606380 | US00606590  US00607572 | US00607576 | US00607588 | US00605199 | US00606172  US00601073 | US00606516 | US00604638 | US00605203 | US00606177  US00605520 | US00606517 | US00604639 | US00605206 | US00606178  US00605521 | US00606518 | US00604640 | US00606144 | US00606594  US00605531 | US00606522 | US00604641 | US00606148 | US00606598  US00605533 | US00606530 | US00604642 | US00606149 | US00606602  US00605535 | US00606531 | US00604643 | US00606150 | US00606603  US00605539 | US00603306 | US00604644 | US00606156 | US00606605  US00605541 | US00603486 | US00604645 | US00606158 | US00606607  US00605543 | US00604631 | US00604763 | US00606161 | US00607587  US00605545 | US00604632 | US00604769 | US00606166 | US00607597  US00605547 | US00604633 | US00605180 | US00606167 | US00607697  US00605549 | US00604634 | US00605193 | US00606168 | US00607704  US00606512 | US00604635 | US00605194 | US00606169 | US00607707  US00606513 | US00604636 | US00605195 | US00606170 | US00607723  US00606515 | US00604637

特此公告。

飞利浦中国(投资)有限公司

日期:2016-1-26

免责声明
结果来源于特定医疗机构,其他医疗机构未必能够获得相同结果。实际结果可能因具体情况而异。
飞利浦关于除颤仪主动召回的公告 - 飞利浦