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.
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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.
FDA Orders Philips To Bolster Communications Around Recalled Breathing Machines, Calls Notification Efforts ‘Inadequate’
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.
Royal Philips will begin this month the unenviable task of repairing and replacing millions of BiPAP, CPAP and other mechanical ventilator devices that were recalled by the manufacturer in June. The effort will take a full year, Philips says.