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
The Food and Drug Administration May 23 announced that Medline Industries, a firm marketing and distributing Chinese-manufactured plastic syringes within the U…
Headline
The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to…
Headline
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing…
Headline
U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co.…
Headline
The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19…
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…