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Company that made millions of defective sleep apnea machines ordered to overhaul manufacturing

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Sleep Apnea News

Medical Devices,Medical Technology,U.S. Food And Drug Administration

The company responsible for a global recall of sleep apnea machines is now legally barred from resuming production at U.S. facilities until it meets a number of safety requirements. The agreement Tuesday with federal officials is a major step toward resolving a massive medical device recall that has dragged on for years. U.S.

FILE - Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device at his home, Oct. 20, 2022, in Marysville, Ohio. The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements under a long-awaited settlement announced Tuesday, April 9, 2024 by federal officials.

“This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk,” U.S. Attorney Eric Olshan said in a statement. “I worry about my long-term health,” Reed said. “I used this machine for years and no matter what money I might get out of this, what’s going to happen?”

 

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