20.5 C
New York

17 million CPAP masks recalled for ‘serious’ safety issue involving magnets

Published:

The U.S. Food and Drug Administration (FDA) has recalled millions of continuous positive airway pressure (CPAP) masks due to “serious safety concerns.”

According to the FDA, the approximately 17 million recalled Philips Respironics CPAP or bilevel positive airway pressure (BiPAP) masks “have magnets … and can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body.”

The recalled devices include:

  • Amara View Full Face Mask
  • DreamWisp Nasal Mask
  • DreamWear Full Face Mask
  • Wisp and Wisp Youth Nasal Mask
  • Therapy Mask 3100 NC/SP

As of August 30, 2022, Philips reported 14 serious injuries and zero deaths resulting from the use of the masks.

The FDA says that the CPAP masks can endanger the mask user or even people who are near the mask user.

The FDA lists the types of metallic metal devices that could negatively interact with the recalled CPAP masks, leading to injury or death:

  • Pacemakers 
  • Implantable cardioverter defibrillators
  • Metallic stents (such as aneurysm, coronary, tracheobronchial, and biliary)
  • Neurostimulators (such as hypoglossal nerve stimulators)
  • Magnetic metallic implants, electrodes, and valves placed in upper limbs, torso, neck, or head
  • Cerebral spinal fluid shunts (such as ventriculoperitoneal shunt) 
  • Aneurysm clips
  • Embolic coils 
  • Intracranial aneurysm intravascular flow disruption devices
  • Metallic cranial plates, screws, burr hole covers, and bone substitute devices
  • Ocular implants (such as glaucoma implants and retinal implants; intraocular lenses placed during cataract surgery are not impacted)
  • Certain contact lenses with metal 
  • Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants) 
  • Magnetic denture attachments 
  • Implantable ports and pumps (such as insulin pumps)
  • Metallic gastrointestinal clips
  • Certain metallic joint replacements
  • Devices labeled as Magnetic Resonance (MR) Unsafe
  • Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
  • Metallic splinters in the eye
  • Metallic shrapnel in the body

Potential risks of the CPAP masks interfering with metal/medical devices inside the body include:

  • For cerebral spinal fluid and ventriculoperitoneal shunts: potential increased pressure on the eye or brain, which may be fatal.
  • For aneurysm clips: disrupted suture lines or clip separation, which may be fatal.
  • For pacemakers: heart block or irregular heartbeat, which may be fatal. 
  • For cardioverter defibrillators: may fail to shock, which may be fatal.
  • For neurostimulators: compression of the brain, seizures, or lead migration, which may be fatal.

The FDA says that users may continue using the recalled mask, as long as the user and people near the user, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks. 

If you have questions about the recall, you can contact Philips Customer Care Solutions Center at 1-800-345-6443 or visit their website at www.usa.philips.com.

In June 2021, Philips recalled three to four million CPAP machines due to possible health risks associated with sound-dampening polyester-based polyurethane foam used in the devices.

JOIN OUR NEWSLETTER

Get the hottest daily trucking news

This Week in Trucking

Videos