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.