(Reuters) – A U.S. federal court has issued an order to restrict the production and sale of new Philips sleep apnea machines at several facilities across the country, the Food and Drug Administration said on Tuesday.
The U.S. District Court for the Western District of Pennsylvania has signed what is known as a consent decree to halt sales and production until certain requirements are met.
In January, the Dutch health technology company had said it would not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with an agreement with the FDA.
The agreement follows the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 due to concerns that the foam used to reduce noise from the devices could degrade and become toxic, leading to potential cancer risks.
Tuesday's order also requires the implementation of a recall remediation plan, agreed upon by the FDA and Philips, to help ensure that relief is provided to patients affected by the recall.
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