Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks are worn by a person using bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines to support breathing. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environment.

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.

Philips Respironics (Philips) is recalling certain Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks due to a serious safety concern. The recalled masks have magnetic headgear clips to hold them in place. The magnets 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.

The FDA issued a safety communication, Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices about this topic which includes more information on the types of medical devices and objects that may be affected.

As of September 9, 2022, there have been 43 complaints, 14 of those were serious injuries, associated with this issue. The FDA is not aware of any associated deaths.

Phillips Respironics issued a press release about this issue on September 6, 2022. The press release offered the following recommendations:

The FDA’s safety communication Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices offers additional recommendations for health care providers, patients, and their caregivers.

Patients and health care providers with questions may contact Philips Respironics’ customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

01/31/2023