This is an update to our CPAP and BiPAP face and nasal masks that contain magnets safety alert.
We are continuing to monitor the occurrence of adverse events from interactions between implantable medical devices and masks that have magnetic components. We are in communication with companies supplying these devices in Australia and other international regulators about this problem.
- ResMed Pty Ltd has worked with the TGA to undertake a Product Defect Correction Product, released 20 November 2023. This correction updates the contraindications to strengthen the current labelling and warning related to magnets. More information can be found on ResMed Masks with Magnets.
- Philips Electronics Australia Ltd has worked with the TGA to undertake a Product Defect Correction, released 27 October 2022, to update the contraindications and warnings to strengthen the current labelling and warnings related to magnets. More information can be found on Philips’ face and nasal masks with magnetic clips.
- On 6 September 2022, both Philips Respironics and the US Food and Drug Administration (FDA) released a statement/safety communication relating to this issue.
We strongly encourage you to report all problems associated with face and nasal masks that contain magnets. Your reports help us monitor the performance and safety of medical devices.
Visit Report a problem or side effect to complete the online form and share any problems you may be experiencing. Please include as much information as you can, including detail about the mask which contains magnets, and the implanted device which was affected.