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Philips Recalls BiPAP and CPAP Masks Due to Magnets

The FDA alerted the public that Philips recalled certain masks used with its BiPAP and CPAP machines. This recall comes on the heels of the company’s recall last week for BiPAP machines contaminated with plastic. Philips pulled the masks due to safety concerns over the magnets that may result in serious injury or even death. These magnets can interfere with implanted metallic medical devices and objects in the body. This is another development in the ongoing safety hazards associated with Philips CPAP and BiPAP devices. 

Magnets in Philips CPAP and BiPAP Pose Health Dangers 

Philips warned patients, caregivers, and doctors of the increased risk of injury or death associated with its BiPAP and CPAP masks with magnets. Users or those nearby patients may experience severe adverse health complications if the magnets interfere with vital metallic implants. Patients wear the recalled masks when using the BiPAP or CPAP machines to alleviate their sleep apnea. However, Philips designed them with magnetic headgear clips to ensure the masks remain in the correct position during sleep. When these magnets affect the functioning of metallic devices in users or those close by, it can result in fatal consequences. 

The masks are for single-patient use in the home and multi-patient use in clinical environments. Masks affected by the recall include: 

• Amara View Full Face Mask
• DreamWisp Nasal Mask
• DreamWear Full Face Mask
• Wisp and Wisp Youth Nasal Mask
• Therapy Mask 3100 NC/SP

Possible Health Problems Related to Magnets in Philips Masks

If an individual using a mask or a person in close proximity to a CPAP or BiPAP patient has an implanted metallic device, they may suffer health complications. As of August 30, 2022, Philips reported 14 serious injuries caused by the magnets in the recalled masks. Within the 14 reports, people experienced: 

• Pacemaker failure requiring a replacement
• The need for shunt adjustment
• Resetting of automatic implantable cardioverter defibrillator
• Arrhythmia
• Cognitive changes
• Headaches
• Heart rate changes 
• Seizures
• Irregular blood pressure

The FDA noted that the magnets may interfere with a wide variety of implanted metallic devices. Metallic stents, aneurysm clips, pacemakers, insulin pumps, and cardiovascular defibrillators are among 21 devices at risk of malfunction. 

Philips and FDA Warn Patients with Metallic Implants to Stop Using Masks

Philips and the FDA advised patients with metallic implants to stop using the recalled magnetic masks and switch to a non-magnetic option. In the meantime, patients should keep the magnetic masks at least 6 inches away from metallic medical implants and medical devices susceptible to magnetic fields. Household members, bed partners, and caregivers with metallic implants are also at risk if they get too close to the magnetic masks. Individuals without metallic implants can resume using the recalled masks. Philips has distributed more than 17 million masks containing magnetic clips to date.