The Food and Drug Administration (FDA) has issued a safety communication regarding the recall of certain Philips Respironics masks used with bilevel positive airway pressure (also known as Bi-Level PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern.
The recalled masks include the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks.
According to the FDA, the magnetic headgear clips used to attach the headgear straps to the mask can “potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask.”
To date, Philips has received reports of 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to the use of the recalled masks. Patients should stop using the recalled masks and switch to a non-magnetic mask if one is available. The recalled mask should be kept at least 6 inches away from metallic medical implants, metallic objects in the body, and other medical devices that can impacted by the magnetic fields.
“This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We strongly encourage providers and at-risk patients to review this important safety information and follow our recommended actions to reduce the potential for harm from these products.”
The Agency is working with Philips to make sure the company takes appropriate action to correct the recalled devices. While this recall is not associated with the polyester-based polyurethane foam issue for certain ventilators, BiPAP and CPAP machines recalled in June 2021, it does affect masks used with some of those devices.
Adverse events related to the recalled masks should be reported to the FDA’s MedWatch program.
- Certain Philips Respironics masks for BiPAP, CPAP machines recalled due to safety issue with magnets that may affect certain medical devices: FDA safety communication. News release. September 6, 2022. https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect
- Philips Respironics alerts customers worldwide of updated instructions and labeling of specific sleep therapy masks that contain magnetic headgear clips due to potential risk of serious injury. News release. September 6, 2022. https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2022/20220906-philips-respironics-alerts-customers-worldwide-of-updated-instructions-and-labeling-of-specific-sleep-therapy-masks-that-contain-magnetic-headgear-clips-due-to-potential-risk-of-serious-injury.html