Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that certain CPAP Masks with magnets can cause potential injuries or death when use of a mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body.
If you have a pacemaker or other implanted medical device that can be affected by magnets, we recommended that you DO NOT use a CPAP mask with magnets.
Click here to read more information from the FDA.
If you have a pacemaker or other implanted medical device that can be affected by magnets, we recommended that you DO NOT use a CPAP mask with magnets.
Click here to read more information from the FDA.
From the Food And Drug Administration:
Date Issued: September 6, 2022
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masksExternal Link Disclaimer used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets (placements shown by black circles in the picture below) and can cause potential injuries or death when use of a recalled mask with magnets interferes 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. Additionally, 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.
Device DescriptionThe recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg).
Date Issued: September 6, 2022
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masksExternal Link Disclaimer used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets (placements shown by black circles in the picture below) and can cause potential injuries or death when use of a recalled mask with magnets interferes 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. Additionally, 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.
Device DescriptionThe recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg).
- Figure 1: Amara View Full Face Mask
- Figure 2: DreamWisp Nasal Mask
- Figure 3: DreamWear Full Face Mask
- Figure 4: Wisp and Wisp Youth Nasal Mask
- Figure 5: Therapy Mask 3100 NC/SP
Below is a notification letter from Philips Respironics
| respironics_magnet_warning_letter_-_patient_version_-_9-14-22.pdf |
