Magnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individuals
CanadaMagnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individuals
Recalling Firm: Communications and Public Affairs Branch
Reason for Recall / Hazard
TranslatedNew safety information
Product Description & Identification
TranslatedSTOP 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
TranslatedPhilips 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. |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Magnets in certain Philips Respironics sleep therapy masks may cause serious injury to some individuals?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmCommunications and Public Affairs Branch
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