September 06, 2022
The U.S. Food and Drug Administration is alerting patients, caregivers, and healthcare providers that Philips Respironics has recalled specific masks used with BIPAP and CPAP machines due to a serious safety concern. The recalled masks have magnetic headgear clips to hold them in place which may affect certain medical devices.
The recalled masks with magnets (shown by black circles in the picture below) can cause potential injuries or death when used to interfere with certain implanted metallic medical devices and metallic objects in the body. These potential adverse events can occur in people who use the masks, or in people near a person using the mask. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.
Five mask types are affected by this recall:
- DreamWisp
- DreamWear Full Face
- Amara View
- Wisp & Wisp Youth
- Therapy Mask 3100
Click here for FDA details on Philips Mask Recall
MonsterCPAP is in contact with Philips Canada to better understand the implications of this U.S. recall to our customers and the next steps in Canada. Updated information will be shared as it becomes available. Out of caution, screen yourself and your bed partners before choosing a CPAP mask with magnets. Click here to learn if you should use a CPAP mask with magnets.
Click here for ResMed's Field Safety Notice About The Use Of Masks With Magnets
See the Full List of Resmed Masks with Magnets here.