Magnets in certain Philips Respironics sleep therapy masks may cause serious inj...
Reason for Recall / Hazard
New safety information
Product Description & Identification
STOP USING the affected mask if you or any of your household members, caregivers or bed partners have implanted metallic medical devices or objects that may be affected by magnets, including but not limited to:PacemakersImplantable cardioverter defibrillators (ICD)NeurostimulatorsMagnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (neck and head)CSF (cerebral spinal fluid) shunts (e.g., VP [ventriculo peritoneal] shunt)Aneurysm clipsEmbolic coilsIntracranial aneurysm intravascular flow disruption devicesMetallic cranial plates, screws, burr hole covers, and bone substitute devicesMetallic splinters in the eyeOcular implants (e.g., glaucoma implants, retinal implants)Certain contact lenses with metalImplants 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 attachmentsMetallic gastrointestinal clipsMetallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)Implantable ports and pumps (e.g., insulin pumps)Hypoglossal Nerve StimulatorsDevices labelled as MR (magnetic resonance) unsafeMagnetic metallic implants not labelled for MR or not evaluated for safety in a magnetic fieldAsk your physician or health care provider to help you find another mask without magnets that you can use with your device. You can also contact Philips Respironics customer service at 1-800-345-6443 or the Durable Medical Equipment (DME) provider that supplied you with the affected mask for more information on non-magnetic mask options.Once you have a new mask, properly dispose of the mask that has magnets.If you or any of your household members, caregivers or bed partners have implanted metallic medical devices or objects that can be affected by magnetic fields but that are NOT on the list above:Ensure the mask is kept at least 6 inches (approximately 15 cm) away from any implanted metallic medical devices or objects that may be affected by magnetic fields. You can continue using your mask, or you can follow the steps outlined above to replace it.For people without metallic devices or objects in their bodies:You can keep using your mask if you, your household members, caregivers or bed partners do not have implanted metallic medical devices or objects in the body.Report any health product-related adverse reactions or complaints to Health Canada.
Affected Products
Philips Respironics sleep therapy masks with magnets in the headgear clips or straps (Amara View; DreamWisp; DreamWear; Wisp and Wisp Youth; and Therapy Mask 3100 NC/SP)
Additional Source Details
| Field | Value |
|---|---|
| N I D | 64582 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/magnets-certain-philips-respironics-sleep-therapy-masks-may-cause-serious-injury-some |
| Issue | New safety information |
| Title | Magnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individuals |
| Product | Philips Respironics sleep therapy masks with magnets in the headgear clips or straps (Amara View; DreamWisp; DreamWear; Wisp and Wisp Youth; and Therapy Mask 3100 NC/SP) |
| Archived | 0 |
| Category | Medical devices |
| Last updated | 2022-09-26 |
| Organization | Communications and Public Affairs Branch |
| What you should do | STOP USING the affected mask if you or any of your household members, caregivers or bed partners have implanted metallic medical devices or objects that may be affected by magnets, including but not limited to:PacemakersImplantable cardioverter defibrillators (ICD)NeurostimulatorsMagnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (neck and head)CSF (cerebral spinal fluid) shunts (e.g., VP [ventriculo peritoneal] shunt)Aneurysm clipsEmbolic coilsIntracranial aneurysm intravascular flow disruption devicesMetallic cranial plates, screws, burr hole covers, and bone substitute devicesMetallic splinters in the eyeOcular implants (e.g., glaucoma implants, retinal implants)Certain contact lenses with metalImplants 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 attachmentsMetallic gastrointestinal clipsMetallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)Implantable ports and pumps (e.g., insulin pumps)Hypoglossal Nerve StimulatorsDevices labelled as MR (magnetic resonance) unsafeMagnetic metallic implants not labelled for MR or not evaluated for safety in a magnetic fieldAsk your physician or health care provider to help you find another mask without magnets that you can use with your device. You can also contact Philips Respironics customer service at 1-800-345-6443 or the Durable Medical Equipment (DME) provider that supplied you with the affected mask for more information on non-magnetic mask options.Once you have a new mask, properly dispose of the mask that has magnets.If you or any of your household members, caregivers or bed partners have implanted metallic medical devices or objects that can be affected by magnetic fields but that are NOT on the list above:Ensure the mask is kept at least 6 inches (approximately 15 cm) away from any implanted metallic medical devices or objects that may be affected by magnetic fields. You can continue using your mask, or you can follow the steps outlined above to replace it.For people without metallic devices or objects in their bodies:You can keep using your mask if you, your household members, caregivers or bed partners do not have implanted metallic medical devices or objects in the body.Report any health product-related adverse reactions or complaints to Health Canada. |