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

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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 by federal officials.

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 …WASHINGTON —

Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep. Left untreated, sleep apnea can lead to dangerous drowsiness and increased risk of heart attack. “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?” An FDA inspection of Philips’ Pennsylvania offices in the fall of 2021 uncovered a spate of red flags, including emails suggesting the company was warned of the problem with its foam six years before the recall.

 

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