(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.
(Reporting by Christy Santhosh; Editing by Maju Samuel)
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