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 is now legally barred from resuming production at U.S. facilities until it meets a number of safety requirements.

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Lawyers for the federal government alleged that the company failed to comply with good manufacturing practices needed to ensure device safety. The company did not admit to the allegations, according to the court filing. Jeffrey Reed, of Marysville, Ohio, experienced persistent sinus infections and two bouts of pneumonia during the seven years he used a Philips machine.

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.

 

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