17 million CPAP masks recalled for ‘severe’ security subject involving magnets

The U.S. Meals and Drug Administration (FDA) has recalled thousands and thousands of steady optimistic airway stress (CPAP) masks as a consequence of “severe security considerations.”

In accordance with the FDA, the roughly 17 million recalled Philips Respironics CPAP or bilevel optimistic airway stress (BiPAP) masks “have magnets … and may trigger potential accidents or dying when use of a recalled masks with magnets interferes with sure implanted metallic medical gadgets and metallic objects within the physique.”

The recalled gadgets embrace:

  • Amara View Full Face Masks
  • DreamWisp Nasal Masks
  • DreamWear Full Face Masks
  • Wisp and Wisp Youth Nasal Masks
  • Remedy Masks 3100 NC/SP

As of August 30, 2022, Philips reported 14 severe accidents and nil deaths ensuing from using the masks.

The FDA says that the CPAP masks can endanger the masks person and even people who find themselves close to the masks person.

The FDA lists the sorts of metallic steel gadgets that would negatively work together with the recalled CPAP masks, resulting in damage or dying:

  • Pacemakers 
  • Implantable cardioverter defibrillators
  • Metallic stents (equivalent to aneurysm, coronary, tracheobronchial, and biliary)
  • Neurostimulators (equivalent to hypoglossal nerve stimulators)
  • Magnetic metallic implants, electrodes, and valves positioned in higher limbs, torso, neck, or head
  • Cerebral spinal fluid shunts (equivalent to ventriculoperitoneal shunt) 
  • Aneurysm clips
  • Embolic coils 
  • Intracranial aneurysm intravascular movement disruption gadgets
  • Metallic cranial plates, screws, burr gap covers, and bone substitute gadgets
  • Ocular implants (equivalent to glaucoma implants and retinal implants; intraocular lenses positioned throughout cataract surgical procedure will not be impacted)
  • Sure contact lenses with steel 
  • Implants to revive listening to or stability which have an implanted magnet (equivalent to cochlear implants, implanted bone conduction listening to gadgets, and auditory brainstem implants) 
  • Magnetic denture attachments 
  • Implantable ports and pumps (equivalent to insulin pumps)
  • Metallic gastrointestinal clips
  • Sure metallic joint replacements
  • Gadgets labeled as Magnetic Resonance (MR) Unsafe
  • Magnetic metallic implants not labeled for MR or not evaluated for security in a magnetic discipline
  • Metallic splinters within the eye
  • Metallic shrapnel within the physique

Potential dangers of the CPAP masks interfering with steel/medical gadgets contained in the physique embrace:

  • For cerebral spinal fluid and ventriculoperitoneal shunts: potential elevated stress on the attention or mind, which can be deadly.
  • For aneurysm clips: disrupted suture traces or clip separation, which can be deadly.
  • For pacemakers: coronary heart block or irregular heartbeat, which can be deadly. 
  • For cardioverter defibrillators: could fail to shock, which can be deadly.
  • For neurostimulators: compression of the mind, seizures, or lead migration, which can be deadly.

The FDA says that customers could proceed utilizing the recalled masks, so long as the person and other people close to the person, don’t have any of the implanted metallic medical gadgets or metallic objects within the physique listed above that could be affected by the magnets within the masks. 

If in case you have questions concerning the recall, you may contact Philips Buyer Care Options Middle at 1-800-345-6443 or go to their web site at www.usa.philips.com.

In June 2021, Philips recalled three to 4 million CPAP machines as a consequence of potential well being dangers related to sound-dampening polyester-based polyurethane foam used within the gadgets.

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