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FDA Orders Philips To Bolster Communications Around Recalled Breathing Machines, Calls Notification Efforts ‘Inadequate’

 
• By Shawn M. Schmitt

The US FDA on 10 March sent a letter to Philips Respironics that orders the company to beef up its recall communications, among other directives. The agency is worried about what it perceives as the firm’s lackluster notification activities around the June 2021 recall of millions of BiPAP, CPAP, and other mechanical ventilator devices.

Philips corporation sign.
• Source: Alamy

Calling the company’s efforts to notify customers about its recall of breathing machines “inadequate,” the US Food and Drug Administration on 10 March sent a letter to Philips Respironics that orders the manufacturer to beef up its recall communications, among other directives.

Philips 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...

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