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US federal court orders to restrict production of Philips' sleep apnea devices
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US federal court orders to restrict production of Philips' sleep apnea devices
Apr 9, 2024 2:13 PM

April 9 (Reuters) -

A U.S. federal court issued a decree to restrict the

production and sale of Philips' new sleep apnea

machines at several facilities in the country, the Food and Drug

Administration said on Tuesday.

The U.S. District Court for the Western District of

Pennsylvania has entered into what is known as a consent decree

to curb the sale and production until certain requirements are

met.

In

January

, the Dutch health technology company had said that it will

not sell new devices to treat sleep apnea in the United States

in the coming years as it works to comply with a settlement with

the FDA.

The agreement followed the recall of millions of

breathing devices and ventilators used to treat sleep apnea in

2021 because of concerns that foam used to reduce noise from the

devices could degrade and become toxic, carrying potential

cancer risks.

Tuesday's decree also requires implementation of a

recall remediation plan, agreed to by the FDA and Philips, to

help ensure relief is provided to patients impacted by the

recall.

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