2023 PHILIPS UPDATED INSTRUCTIONS FOR SLEEP THERAPY MASKS CONTAINING MAGNETIC CLIPS
All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.
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
Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443 (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options. Patients may also contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice.
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:
- Implantable cardioverter defibrillators (ICD)
- 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 clipsa
- 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
This statement concerns all masks listed below:
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp and Wisp Youth Nasal Mask
- Therapy Mask 3100 NC/SP
2021 PHILIPS RESPIRONICS RECALL
- Philips Respironics has issued a voluntary recall notification (U.S. only) / field safety notice (International Markets) for specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
- Philips Respironics has advised of potential health risks related to sound abatement foam used in specific devices including some DreamStation CPAPs and informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
- For more information about the 2021 Philips Respironics recall, including which devices are affected, please visit the Philips Respironics website at www.philips.com/src-update or call Philips Respironics at (877) 907-7508.
- If you have questions about how this matter might affect your health or your therapy, please contact your physician.
Click here to find a suitable replacement for your Philips Respironics CPAP or Ventillator device.