The U.S. Food and Drug Administration (FDA) has asked Philips to conduct more tests on the foam used in its recalled ventilators, after the agency found several new issues at the Dutch company’s manufacturing facility. The medical equipment company recalled some breathing devices and ventilators in June because of a silicone-based foam part that might degrade and become toxic, potentially causing cancer. The FDA noted, in a so-called form 483, that between April 2016 and January 2021, Philips was aware of 14 instances of issues related to potential foam degradation with its different sleep and respiratory devices. Philips, which in September said it will repair and replace the 15 million devices recalled globally, did not immediately respond to a request for comment. The company has not sufficiently demonstrated that other devices containing this foam should not also be recalled, and its risk analysis was inadequate, the agency said in the …
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