Philips Medical Device Correction Information
On September 6, 2022, Philips Respironics alerted 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 device industry.
Please reference the links below to determine if your mask is affected. Please note that even if your mask is affected, you may not need to take action and should continue using your mask as prescribed. Please reference the Contraindications section below to determine if you need to take action regarding your current mask.
If you are not affected, please keep your current mask and continue your normal sleep therapy.
CONTRAINDICATIONS
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)
- 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
IMPACTED MASKS
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.
Amara View Full Face Mask
DreamWear Full Face Mask
DreamWisp Nasal Mask
Wisp and Wisp Youth Nasal Mask
If you would like to remove the magnets from your mask immediately, straps can be threaded directly through the headgear on the Amara View and the Wisp.
Amara View: Push the magnetic piece out of the frame. On the bottom straps, thread the end (the portion with the Velcro) through the frame and reattach the Velcro.
Wisp: Remove the magnetic piece from the frame. On the bottom straps, thread the end (the portion with the Velcro) through the frame and reattach the Velcro.
For the Dream Wisp and Dreamwear Full Face Mask, please contact Sleep Central for additional mask options only if you are affected by contraindications.
We thank you for your patience in regards to this device correction.
Geroulds is in frequent communication with Philips Respironics and will continue to post updates to this page as we receive more information. If you have further questions, please contact us at Gerould's Healthcare Center (geroulds.com)