The FDA said that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a safety concern that involves magnets.
The machines help people with conditions that include obstructive sleep apnea, respiratory insufficiency or respiratory failure, as well as health conditions that cause pauses in breathing during sleep.
Five mask types are affected by the recall: the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks, according to a press release from the FDA.
The magnets can affect the movement of certain implanted metallic medical devices, which could cause injury or death to the mask user or the person sleeping near the mask user.
The FDA said the magnets could also affect people or those near them who have metallic objects in their bodies, such as shrapnel or splinters in their eyes.
Philips reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to the use of the recalled masks.
The FDA has provided recommendations for users, caregivers and health care providers concerning the use of the recalled masks, including the submission of medical device reports by health professionals and manufacturers.