Philips

飞利浦

(NYSE: PHG)

（纽约证券交易所：PHG）

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continues to have serious respiratory device recalls, more than three years into a serious safety crisis for its Respironics business.

继续发生严重的呼吸设备召回事件，三年多以来其呼吸系统业务陷入严重的安全危机。

Yesterday, the FDA designated a recall of Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilators as Class I, it’s most serious level. The affected devices have had numerous software errors, including an inaccurate display of oxygen being delivered to the patient, false power loss or battery depleted alarms, volume measurement inaccuracies, and more.

昨天，FDA将Trilogy Evo、Trilogy EV300、Trilogy Evo O2、Trilogy Evo通用呼吸机指定为I级召回，这是最严重的级别。受影响的设备出现了许多软件错误，包括输送给患者的氧气显示不准确，电源丢失或电池耗尽报警错误，体积测量不准确等等。

There is also a previously reported safety issue involving accumulation of environmental debris on the internal machine flow sensor, which could partially block pressure, volume, or air flow..

先前报道的安全问题还涉及内部机器流量传感器上的环境碎片积聚，这可能会部分阻塞压力、体积或气流。。

The have been nine injuries and one death related to the problems, according to the FDA.

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The FDA said Philips Respironics sent all affected customers an Urgent Medical Device Correction – Update on July 16 that they immediately update device software to the latest version, and follow a user manual addendum that requires ta Phillps-approved particulate filter to prevent environmental contamination..

FDA表示，飞利浦呼吸系统公司（Philips Respironics）于7月16日向所有受影响的客户发送了一份紧急医疗器械修正更新报告，要求他们立即将设备软件更新为最新版本，并遵循用户手册附录，该附录要求ta Phillps批准的颗粒过滤器防止环境污染。。

The FDA has more details about the Class I recall on its website.

FDA在其网站上有关于I类召回的更多详细信息。

Since early 2021, Philips has been grappling with recalls involving millions of CPAPs and other respiratory devices. (Here’s MassDevice‘s timeline of Philips’ problems.)

自2021年初以来，飞利浦一直在努力应对涉及数百万CPAP和其他呼吸设备的召回。（这是MassDevice关于飞利浦问题的时间表。）

When it comes to the major recall involving sound abatement foam that could potentially degrade and get into airways, Philips in April finalized a consent decree with the U.S. Department of Justice and FDA that provided a roadmap for resolving the Philips Respironics recall. Philips soon settled personal injury claims in the U.S.

当涉及可能降解并进入气道的降噪泡沫的重大召回时，飞利浦于4月与美国司法部和FDA达成了一项同意令，为解决飞利浦Respironics召回提供了路线图。飞利浦很快解决了美国的人身伤害索赔。

for $1.1 billion and is also paying at least $613 million to settle economic loss claims..

并支付至少6.13亿美元以解决经济损失索赔。。