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Sunday, June 23, 2024

Philips stops promoting sleep apnea machines in US following mass recollects

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Philips is halting gross sales of its recalled sleep apnea machines within the US after discovering they have been pumping foam particles into customers’ airways. In its earnings report on Monday, the corporate says it won’t promote new CPAP or BiPAP units within the US till it meets the necessities outlined by the Meals and Drug Administration.

Philips first issued a recall on its sleep apnea machines in 2021 over “potential well being dangers.” The recall consists of units made between 2009 and April twenty first, 2021, and stems from a polyester-based polyurethane foam Philips included within the machines to attenuate sound and vibration. As famous by Philips, that foam “can break down,” main the individual utilizing the gadget to breathe it in or swallow it, leading to potential damage.

The corporate says it has reached a consent decree with the Division of Justice and FDA. It doesn’t go into element concerning the phrases of the settlement as a result of it’s nonetheless pending approval by a court docket. Nevertheless, we do know that Philips will nonetheless present service to sleep and respiratory units within the US and also will proceed to promote the machines exterior of the US. Philips, which is headquartered within the Netherlands, has put aside €363 million (about $394 million) to handle the FDA’s necessities.



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