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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Philips Announces CEO Succession In Midst Of Massive Recall
Philips CEO Frans van Houten will leave the company in October amid a massive recall of ventilators and related products. Roy Jakobs will succeed van Houten as CEO and president effective 15 October, Philips said.
Philips In Talks With DOJ Over Breathing Machine Recalls
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.
Escalation: FDA Wants Philips To Repair, Replace Or Give Refunds For Recalled Breathing Machines
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.