飞利浦关于移动式摄影X射线机主动召回的公告（Recall-2026-04)

尊敬的用户，您好!

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。

Philips已获悉一个潜在的安全问题，如果用户在清洁或消毒 MobileDiagnosst wDR系统时使用了过量的液体，或将液体直接喷洒在系统上，则液体有可能进入把手按钮的边缘，从而导致金属腐蚀或覆盖层连接器发生短路。

(召回文件内部编号：Recall-2026-04)

飞利浦将向受影响客户发放主动召回通知，告知用户:

可以按照预期用途继续使用您的系统。

• 如果发生意外移动：

- 按下紧急停止按钮以防止进一步移动

- 让设备干燥。干燥后，系统将按预期运行。

• 清洁期间:

- 勿将消毒剂直接喷洒在按钮上，否则可能导致电气短路或金属腐蚀。

- 遵循使用说明书 (IFU) 中维护、清洁和处置章节的清洁说明。

Philips 将安排 Philips 现场维修工程师 (FSE) 到现场实施现场措施 (参考 FCO71200255)。

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三级召回。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。

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特此公告。

飞利浦中国（投资）有限公司

更新日期：2026-03-03