October 24, 2022

FDA: Philips Respironics recalls certain BiPAP, CPAP masks

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on October 19 identified the recall by Philips Respironics of certain masks for BiPAP and CPAP machines as Class I, the most serious.

The recall was initiated because magnetic headgear clips that hold the masks in place can cause injury or death if patients who use them, or those near patients who use them have certain implanted metallic medical devices or metallic objects in their bodies, such as pacemakers, implantable cardioverter defibrillators, or metallic coronary stents.

As of September 9, there have been 43 complaints, 14 of which were serious injuries, and no deaths associated with this issue.

Distribution dates were January 1, 2015, to September 9, 2022.

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