Philips Respironics Sleep and Respiratory Care
The following Philips Respironics patient interface devices (face and nasal masks) – Amara View Minimal Contact Full-Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, and Therapy Mask 3100 NC/SP – contain magnets.
- Amara View Minimal Contact Full-Face Mask
- DreamWear Full Face Mask
- DreamWisp Nasal Mask with Over the Nose Cushion
- Wisp Nasal Masks and Wisp Youth Nasal Masks
- Therapy Mask 3100 NC/SP
This Urgent Medical Device Correction is intended to inform you that Philips Respironics is updating its existing ‘Contraindications’ and ‘Warning’ of the above masks with magnets to the below.
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)
- 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 the mask. 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.
For a full list of Products affected including Mechanical Ventilators, please visit their website: Philips.com.
For more information on the Mask Recall from Philips, please visit: https://www.fda.gov/medical-devices/letters-health-care-providers/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect