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Philips recalls 17M CPAP, BiPAP masks over magnets that could affect implanted devices

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The impacted masks are pictured in provided photos. The magnet location is shown with black circles. (Credit: FDA) WASHINGTON - Philips Respironics has recalled more than 17 million masks used for people with sleep apnea and other respiratory issues due to a safety issue with magnets that could affect certain implanted medical devices.

The recall was announced on Tuesday by the U.S. Food and Drug Administration after 14 serious injuries were reported, including pacemaker failure, arrhythmia, seizures, and irregular blood pressure.

The recalled masks are worn by a patient when using a bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP) machine and have magnetic headgear clips to hold them in place, officials said.

They are for single-patient use in the home or multi-patient use in a hospital or other clinical settings. The five mask types impacted by the recall are the DreamWisp, DreamWear, Amara View, Wisp, and Wisp Youth masks.The impacted masks are pictured in provided photos.

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