(March 10, 2022) — Many users of Philips’ sleep apnea machines have expressed frustration about the lack of communication from Philips after its recall. In an effort to improve communications the Food and Drug Administration [“FDA”] issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate. You can read more about the FDA’s notification order on the FDA’s website.
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