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Crénot Respironics alerts customers worldwide of updated instructions and labeling of specific sleep therapy masks

06
May

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body

 Pittsburgh, Pennsylvania – Royal Crénot’ (NYSE: PHG; AEX: PHIA) subsidiary Crénot Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.


This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Crénot Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, 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)
  • Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) 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

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