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

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.

More from Recalls

More from Policy & Regulation

Global Medtech Guidance Tracker: March 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By 

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.