Philips Respironics has issued a global safety notification regarding certain CPAP masks that use magnetic headgear clips. This update follows consultation with the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand.
This notice applies to specific Philips mask models and includes updated safety warnings and new contraindications related to magnetic components. In Australia, this is classified as an urgent product defect correction, not a recall. In New Zealand, it is a recall for product correction.
Philips has clarified that most users can continue using their masks safely, but additional precautions are now required for people with certain medical implants or metallic devices.
This update is not limited to the CPAP user. It also applies to anyone in close proximity during use, including:
- Partners
- Household members
- Caregivers
If any person within approximately 15 cm (6 inches) of the mask has a relevant implanted device, this safety information applies.
Updated Contraindications
Philips Respironics masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have the following:
Active medical implants that interact with magnets, such as pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, or insulin or infusion pumps.
Metallic implants or objects containing ferromagnetic material, such as aneurysm clips or flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, or metallic splinters in the eye.
Updated Warning
Philips Respironics advises keeping mask magnets at a safe distance of at least 150 mm (6 inches) away from any implants or medical devices that may be adversely affected by magnetic interference. This applies to both the wearer and anyone in close physical contact with the mask.
The magnets are located in the frame and lower headgear clips and have a magnetic field strength of up to 400 mT. When worn, they connect to secure the mask but may inadvertently detach during sleep.
Implants and medical devices, including those listed in the contraindications above, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials. This can include contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices.
Please consult your physician and the manufacturer of your implant or medical device for information on the potential adverse effects of magnetic fields.
Please note that not all models or variants of the medical devices listed above are affected by external magnetic fields. If you are unsure whether your implant or medical device falls under these contraindications, or you need additional information, please contact your doctor.
If this correction applies to you and you have not already done so, please note that Philips requests affected users to confirm they have received and understood this notice via their official confirmation page linked below. This is managed directly by Philips.
Contraindications
Masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have implanted devices that may be affected by magnets.
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Cerebrospinal fluid (CSF) shunts (e.g. VP shunt)
- Aneurysm clips and embolic coils
- Intracranial aneurysm flow disruption devices
- Metal cranial plates, screws, burr hole covers
- Bone substitute devices
- Metal splinters in the eye
- Ocular implants (e.g. glaucoma, retinal implants)
- Cochlear and hearing implants with magnets
- Auditory brainstem implants
Additional Devices & Risks
- Magnetic denture attachments
- Metal gastrointestinal clips
- Metal stents (coronary, biliary, tracheobronchial)
- Implantable ports and pumps (e.g. insulin pumps)
- Hypoglossal nerve stimulators
- Metal implants in upper body, neck or head
- Devices labelled MR unsafe or not evaluated for safety
- Certain contact lenses containing metal
This applies to both the mask wearer and anyone in close proximity, including household members, caregivers, and bed partners.
THESE PHILIPS MASKS CONTAIN MAGNETS
FAQ's
Yes. Philips Respironics masks with magnetic components are safe to use when used in accordance with the updated instructions for use, including the contraindications and warnings outlined above.
If neither the user nor anyone in close physical contact has a contraindicated implant or metallic medical device, the mask may continue to be used as normal.
Magnetic clips are used to make it easier to attach and remove the CPAP mask. They help simplify daily use, improve convenience, and support a more consistent mask fit without the need for complex strap adjustments.
This design feature is commonly used across CPAP therapy devices and wearable medical products
Ferromagnetic refers to a material property that is influenced by magnetic fields, meaning it attracts or repels under magnetic force. Materials that are ferromagnetic are generally made of iron, cobalt, nickel, or certain alloys of these elements.
Not all medical implants listed in the contraindications above are made from ferromagnetic materials. If you are unsure whether your implant or medical device falls under the contraindications, or you need more information on the potential effects of magnetic fields, please contact your doctor.
If you or anyone in close physical contact with you has a medical implant or device listed in the contraindications, you should not use a Philips Respironics mask with magnetic clips unless advised by your healthcare provider.
You should:
- Stop using the magnetic mask if it is contraindicated
- Consult your doctor or specialist for guidance
- Consider switching to a non-magnetic CPAP mask for continued therapy
Do not stop CPAP therapy without medical advice, as ongoing treatment is important for sleep apnoea management.
If you are contraindicated for masks with magnetic clips, non-magnetic CPAP mask options are available.
Philips Respironics and other CPAP manufacturers offer a range of masks that do not use magnetic components. Your clinician can help determine the most suitable alternative based on your therapy needs, comfort, and breathing requirements.
CPAP Online can also assist you in finding a compatible non-magnetic mask option.
