Philips’ Handling of Massive 2021 Respiratory Device Recall is Unsatisfactory, FDA Says

The FDA “remains unsatisfied” with Philips Respironics’ handling of the recall of its 15 million ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines.

“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” wrote Jeff Shuren, director of the FDA’s CDRH in a recall update Thursday.

At issue is the polyester-based polyurethane foam used in the devices to reduce sound and vibration.

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