Philips Respironics Masks
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with BiPAP 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. 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 Description
The 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
Please read the full recall notice from the FDA. The recalled masks have magnets that 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. Stop use of the recalled mask and switch to a non-magnetic mask if available, if you or someone near you when using the recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed in the recall notice that may be affected by the magnets in the masks.
CPAP, BiPAP, & Mechanical Ventilator Recall June 2021
In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices.
Click here to see the main webpage regarding this recall. Scroll down on that page, or click this link from Philips to see the list of affected products. Affected devices were manufactured before April 26, 2021.
Philips has opened an online portal to check your individual device via its serial number. If your device is affected, you can use the portal to register for a remediation from Philips. If you have already registered through the portal, you can use this link to check on the status of your remediation.
The Recall Support page on the Philips website provides a good overview of the process and a timeline for Philips to provide a resolution.
You can also call Philips at 877-907-7508 to speak with their customer service team directly.