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Who is affected?

Recall of masks containing magnets from Philips

The recall states that mask use is contraindicated for:

  • Patients and their household members
  • Caregivers
  • Bed partners

…that may be in close vicinity to patients using the masks…

…AND that have implanted devices that may be affected by magnets, including but not limited to:

  • Pacemakers
  • Implantable cardioverter defibrillators (ICD)
  • Neurostimulators
  • Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e. neck and head)
  • CSF (cerebral spinal fluid) shunts (e.g., VP (ventriculo peritoneal) shunt)
  • Aneurysm clips
  • Embolic coils
  • Intracranial aneurysm intravascular flow disruption devices
  • Metallic cranial plates, screws, burr hole covers, and bone substitute devices
  • Metallic splinters in the eye
  • Ocular implants (e.g., glaucoma implants, retinal implants)
  • 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
  • Metallic gastrointestinal clips
  • Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
  • Implantable ports and pumps (e.g., insulin pumps)
  • Hypoglossal Nerve Stimulators
  • Devices labeled as MR (magnetic resonance) unsafe
  • Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Warning

Magnets with a magnetic field strength of 400 mT are used in Philip’s masks.

With the exception of the devices identified in the contraindication, ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Note that mask magnets have no effect on non-ferrous devices such as orthodontic appliances.