Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year
The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.
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After being subpoenaed by the US Department of Justice in April, Philips says it is negotiating with the department on a consent decree addressing numerous recalled breathing devices made by Philips Respironics.
The US FDA is weighing whether to force the embattled company to repair, replace or refund recalled BiPAP, CPAP and other mechanical ventilator devices. Philips Respironics may attend an “informal hearing” before the agency decides.