FDA alerts providers to breathing device mask recall
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.