The FDA has placed a Class I label on Philips' recall of certain masks for CPAP and BiPAP machines due to a safety issue with magnets.
The Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks are worn by a person using bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines to support breathing. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environment.
The recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.
Philips Respironics (Philips) is recalling certain Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks due to a serious safety concern. The recalled masks have magnetic headgear clips to hold them in place. The magnets can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body.
As of September 9, 2022, there have been 43 complaints, 14 of those were serious injuries, associated with this issue. The FDA is not aware of any associated deaths.