"We are aware of the September 6, 2022, recall of certain Philips masks due to a safety issue with magnets that may affect some medical devices in or on a patient. ResMed is carefully reviewing the issues outlined in the FDA’s recall report, as we do with any relevant regulatory activity in the market.
We believe our (ResMed) masks are safe to use. While some ResMed masks use magnets in the lower headgear straps and the frame to assist with ease of closure and a secure fit, these masks contain magnets designed to a strength below the guidance from the International Commission of Non-Ionizing Radiation Protection (ICNIRP) for use of magnets in this setting, and ResMed masks provide instructions to users about the use of magnets in proximity to other medical devices. We will consider whether additional work is needed to further demonstrate the continuing safety of our masks that use magnets
ResMed continually evaluates our products against applicable regulatory standards, industry guidance, safety standards, and good clinical practice, as they develop."
ResMed's Field Safety Notice around the use of masks with magnets. Resmed Masks with Magnets include:
- AirFit F20 Full Face Mask
- AirTouch F20 Full Face Mask
- AirFit F30 Full Face Mask
- AirFit F30i Full Face Mask
- AirFit N20 Nasal Mask
- AirTouch N20 Nasal Mask
- AirFit N10 Nasal Mask