Philips issues voluntary recall of certain masks

PITTSBURGH – Philips 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, a commonly used method in sleep therapy devices. 

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing magnetic clips to inform them of the updated instructions and labeling. 

Implanted devices that may be affected by magnets, include but are 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. 

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, they should switch to a non-magnetic mask if available, for continued therapy. 

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. 

For more information about non-magnetic mask options, contact Philips Respironics’ customer service at 1-800-345-6443.