Philips Respironics has recalled more than 17 million masks used with Bilevel Positive Airway Pressure and Continuous Positive Airway Pressure machines because the masks contain magnets that could cause serious injury to people with implanted metallic medical devices or other objects, the Food and Drug Administration announced yesterday. Philips has reported 14 serious injuries related to using the masks, including pacemaker failure, arrhythmia, seizures and irregular blood pressure. BPAP and CPAP machines are used by people with obstructive sleep apnea, respiratory insufficiency or respiratory failure — health conditions that cause breathing pauses during sleep. 

“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,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health.

Related News Articles

Headline
In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an…
Headline
The Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical…
Headline
Commenting yesterday on the Environmental Protection Agency’s proposed standards for ethylene oxide use to sterilize medical devices, AHA encouraged the agency…
Headline
The Environmental Protection Agency May 30 announced its intent to finalize by March 1, 2024, new rules governing emissions from ethylene oxide, the gas…
Headline
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations…
Headline
The Food and Drug Administration yesterday revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require…