![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Philips Recalls Respiratory Devices with Foam Component Problem
Philips Recalls Respiratory Devices with Foam Component Problem
![](https://www.fdanews.com/ext/resources/test/Device_Images6/Warning_RecallStamps.gif?t=1584050994&width=430)
June 16, 2021
Philips has announced a recall of 3.5 million ventilation devices used to treat sleep apnea because of potential health risks linked to a foam component.
In some models of its bi-level positive airway pressure, continuous positive airway pressure and mechanical ventilator devices, the polyurethane sound-abatement foam could degrade into particles that have toxic and carcinogenic effects, the company said.
Philips is taking corrective actions, including issuing updated usage instructions and launching a repair and replacement program for the affected devices.
Upcoming Events
-
21Oct