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Philips Working With U.S. FDA After Mass Ventilator Recall

Royal Philips said it is working closely with the U.S. Food and Drug Administration after the agency asked for more tests on a silicone foam the medical equipment company plans to use to repair ventilators that were recalled earlier this year.

The FDA issued a number of initial findings on Friday following an inspection of a U.S. manufacturing facility. The Dutch company’s subsidiary, Philips Respironics, issued a voluntary recall of certain sleep and breathing devices, and ventilators in June because a polyester-based polyurethane foam which, if it degrades, could potentially become toxic.