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Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year

 
• By Shawn M. Schmitt

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.

The US Food and Drug Administration said on 19 May that over a one-year span it was sent tens of thousands of adverse event reports related to problematic breathing machines made by Philips Respironics.

The company in June 2021 recalled millions of bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices because there’s a risk that users of the products could inhale degraded sound

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More from Policy & Regulation

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A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

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