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飞利浦作为一家领先的健康科技公司，长期致力于生产和研发能满足客户需求的产品及其创新解决方案。确保患者的生命安全是飞利浦产品质量所追求的最重要的最基础的标准。
飞利浦发现如客户未按照使用说明书（IFU）中的规定对其设备进行计划维护，DigitalDiagnost C50系统可能会出现问题。即如客户未按照使用说明书（IFU）的规定每年对可伸缩托架进行一次计划维护，则可伸缩托架内部弹簧平衡器的张力会不可避免地因正常磨损而衰减；如果此时系统的电源又被中断，DigitalDiagnost C50系统的悬吊架可能会意外下降，这可能会导致患者和用户受伤。
飞利浦将向受影响客户发放主动召回通知信函，主动告知有可能发生的问题和如何识别并采取的措施，并提供DigitalDiagnost C50系统使用说明书附录，这也是飞利浦主动承担责任和义务的体现。
根据中国医疗器械召回法规的相关规定，截止至目前，飞利浦正在为受影响客户发送主动召回通知信函。此主动召回在中国的召回级别为二级召回。按《医疗器械召回管理办法》第六条内容要求：“医疗器械经营企业、使用单位应当积极协助医疗器械生产企业对缺陷产品进行调查、评估，主动配合生产企业履行召回义务，按照召回计划及时传达、反馈医疗器械召回信息，控制和收回缺陷产品。”
如您在使用受此次主动召回影响的产品，若有任何疑问，请您致电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。
受影响设备序列号为：
DigitalDiagnost C50:
SN180202, SN160014, SN170005, SN170009, SN170018, SN170091, SN170112, SN180094, SN180146
DigitalDiagnost C50 65:
200018, 210106, 210154, 200051, 210006, 200048, 200023, 210096, 210092, 210019, 210056, 210021, 210108, 200045, 200032, 210067, 210005, 200049, 210039, 220103, 220108, 200017, 200047, 200064, 200065, 210029, 200068, 200069, 220050, 220051, 200083, 210068, 200103, 200108, 200109, 200119, 200122, 200064, SN170010, SN170055, 210003, 210004, SN170072, SN170073, 210087, SN170087, SN170088, SN170109, SN180009, SN180014, SN180029, SN180043, SN180044, SN180059, SN180068, SN180076, SN180085, SN180122, SN180136, SN180152, SN180159, 210157, 210158, 220046, 220096, 220100, 220102, 220105, SN180190, SN190005, SN190006, SN190049, SN190057, SN190058, SN190081, SN190083, SN190128, SN190129, SN190139, SN190144, SN190145, 210016, 210155, SN190151, SN190166, SN190208, SN190209, SN190210, SN200038, 210025, 210033, 220127, SN200045, 220053, 220054, SN180207, 200011, 200014, 210032, 200015, 200041, 200043, 200058, 200060, 200061, 210214, 200070, 200073, 200074, 200077, 200078, 200079, 200080, 200081, 200082, 220117, 200085, 200087, 200089, 210229, 200090, 200091, 200037, 200092, 200093, 200095, 200096, 200098, 200099, 200100, 200101, 200102, 200104, 200105, 200106, 200107, 200110, 200112, 200050, 200113, 200114, 200115, 210227, 200116, 200118, 200120, 200121, 210038, 200123, 200124, 200130, 200133, SN160012, 200036, SN160013, SN160015, SN170002, SN170019, SN170020, 210219, SN170021, SN170022, 210213, 220066, 200030, 210061, SN170023, SN170024, SN170028, SN170030, SN170038, SN170039, SN170040, 200044, SN170042, 210197, SN170043, SN170045, SN170048, SN170049, SN170050, 200063, SN170052, 200033, 210064, SN170060, SN170062, SN170066, SN170068, 200040, 210226, SN170070, SN170075, SN170076, SN170078, 210008, SN170081, SN170082, SN170083, SN170085, SN170086, SN170097, SN170104, SN170111, SN170118, SN170131, SN170132, SN180006, 210035, SN180007, 210167, SN180008, 210145, 210009, SN180010, SN180011, SN180012, SN180015, SN180016, SN180017, SN180020, SN180021, SN180022, SN180023, SN180024, SN180025, SN180028, 210240, SN180032, 210230, SN180033, SN180034, SN180035, 200058, SN180036, SN180038, 220075, SN180045, SN180046, SN180047, SN180048, SN180049, SN180051, 200068, SN180052, 210221, SN180053, SN180054, 210060, SN180055, SN180057, 210112, SN180058, 210175, 220107, SN180061, SN180065, SN180066, 210136, SN180067, 210223, SN180069, 200052, SN180070, 210030, SN180071, SN180072, SN180075, SN180080, SN180086, SN180087, SN180089, SN180090, SN180105, 220023, SN180112, SN180116, SN180120, SN180133, SN180135, 200056, 210074, SN180137, SN180138, SN180139, SN180140, SN180141, SN180142, SN180144, SN180145, SN180150, SN180151, SN180153, SN180154, 210037, 210109, SN180171, 210012, SN180175, SN180176, SN180177, SN180178, SN180179, SN180185, SN180186, SN180187, SN180189, SN180191, SN180195, SN180197, SN180199, 200009, SN180200, SN180203, SN180204, SN180210, SN180214, SN190008, SN190009, SN190013, SN190020, SN190022, SN190025, SN190026, SN190028, SN190029, SN190030, SN190032, SN190033, SN190034, SN190035, SN190036, SN190047, SN190050, SN190051, SN190052, SN190053, SN190054, SN190059, SN190063, SN190064, SN190067,SN190073, SN190074, SN190075, SN190078, SN190079, SN190080, 200031, SN190082, SN190087, SN190088, SN190093, SN190094, SN190096, SN190097, SN190098, SN190099, SN190100, SN190101, SN190102, SN190103, SN190104, SN190105, SN190106, SN190107, SN190108, SN190109, SN190110, SN190111, SN190130, SN190137, SN190138, SN190141, SN190143, SN190146, SN190147, SN190148, SN190149, SN190150, SN190154, SN190159, SN190160, SN190163, SN190169, SN190170, SN190174, SN190175, SN190176, SN190183, 210017, SN190186, SN190187, SN190191, SN190193, SN190198, SN190199, SN190200, SN190206, SN190211, SN190213, SN190214, SN190216, SN200013, SN200016, SN200018, SN200027, 200019, SN200032, 200028, 200041, SN200044, 210150, 210236, 210020, 210101, 210151, SN200049, SN200052, 200047, 210189, 210098, 210105, 210156, 210018, 210078, 210225, 210196, 210191, 210241, 210194, 200014, 200042, 200046, 220052, 220064, 220057, 220116, 220137, 220139, SN170029
DigitalDiagnost C50 65 HAT:
200134, SN180131, SN190140, SN190212, 200117, 200125, 200135, SN180056, SN180063, SN180121, SN180130, SN180184, SN180188, SN190070, SN190071, SN190072, SN190076, SN190077, SN190136, SN190177, SN190185, SN190205, SN190220, SN200020, SN200053, SN190203, 220062, 220078, 210027, 210215, 210216, SN180172, 210235, 210090, 220034, 220036, 210174, 210237, 210011, 210057, 210072, 210208, 200027, 220033, 200034, 200022, 210206, 200053, 200055, 210007, 220061, 210002, 220039, 210083
特此公告。
飞利浦医疗（苏州）有限公司
日期：2023-3-10
