Medtech Insight

It’s Class I For June Recall Of Philips Breathing And Ventilator Devices

22 Jul 2021

• By Shawn M. Schmitt

The US FDA on 22 July designated a recent recall by Royal Philips of certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices as high-risk class I.

A recent recall by Royal Philips of certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices has been designated as high-risk class I by the US Food and Drug Administration.

The agency made its classification decision on 22 July, Reuters reported. The company recalled the devices on 14 June...