The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the US, under a tentative agreement with regulators that could cost it nearly $400 million. Device maker Philips has recalled more than 5 million pressurized breathing machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep. The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on, per the AP. The Dutch manufacturing giant said it has agreed to a consent decree with the FDA and the Department of Justice. The deal hasn't yet been finalized and will have to be approved by a US judge.
Under the tentative agreement's terms, Philips would continue servicing previously sold machines in the US but couldn't sell new ones until it meets corrective actions laid out by the FDA. Company executives said they've set aside $393 million for operational changes and upgrades needed to comply. The FDA's website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions, and more serious problems. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires.
In 2022, the FDA took the rare step of ordering Philips to step up outreach to customers on the recall. At the time, the agency estimated only about half the people in the US with affected machines knew about it. The latest announcement doesn't resolve 675 personal injury lawsuits filed against the company over the devices, which have been consolidated in a federal court in Pennsylvania. More here.
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