More than 17 million masks used with sleep apnea machines recalled due to safety issues
Millions of masks used with sleep apnea machines have been recalled for safety concerns.
Philips Respironics recalled more than 17 million masks used with their continuous positive airway pressure or CPAP and Bi-Level positive airway pressure or Bi-PAP machines.
The Food and Drug Administration says magnets connect and hold the mask components in place but they can affect the function of implanted metallic medical devices like brain stents, aneurysm clips and pacemakers.
At least 14 serious injuries have been reported.
The recalled mask types are DreamWisp Nasal Mask, DreamWear Full Face Mask, Amara View Full Face Mask, Wisp and Wisp Youth Nasal Mask, and Therapy Mask 3100 NC/SP.
The FDA says people can continue to use the products if they, or people around them, do not have implanted metal objects in their bodies.
Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443, for more information about non-magnetic mask options.
for more information from the FDA.