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

 
• 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.

Philips sign.

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 because sound abatement foam used in them could break down over time, posing a risk to patients

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