MedWatch – The FDA Safety Information and Adverse Event Reporting 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

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks 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 above) and can cause potential injuries or death when use of the mask with magnets interferes with certain implanted metallic medical devices or metallic objects in the body.

These potential adverse events can occur in people who use the masks, or 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.

This safety communication provides:

• A list of recalled masks with magnets.
• Potential risks if magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body.
• Recommendations for people who use a recalled mask, as well as people near a person using the mask, caregivers, and health care providers.
• Background on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems with a recalled mask to the FDA.

Related Information

• Letter to Health Care Providers: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices
• FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

Questions?

If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center at 1-800-345-6443 or visit their website at www.usa.philips.com.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

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