San Diego-based ResMed informed users of potential magnetic interference when magnets go near certain implants and medical devices in the body. The company doesn’t require a return of a mask with magnets unless the patient is contraindicated.
All ResMed masks containing magnets remain safe when used in accordance with the field safety notice and updated instructions.
Philips had a similar recall related to magnets and implanted devices just over a year ago.
ResMed provided a patient letter to healthcare providers that includes additional information regarding contraindications. It also has warnings for patients with the affected medical implants or devices.
The company distributed masks with magnets nationwide and globally from 2014 to November 2023. It submitted five reports of serious harm (medical intervention/hospitalization) potentially related to the magnet issue. To date, ResMed reports no permanent injuries or deaths.
Affected masks include certain models of the AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i. Users can identify them by the model number on the cushion or frame of the masks. ResMed notified the FDA and other global regulators.
Contraindicated patients may have or be in close physical contact while using the mask to someone who has active medical implants that interact with magnets, like pacemakers and implantable defibrillators, as well as neurostimulators and insulin and infusion pumps. Other devices include metallic implants with a ferromagnetic material, like stents, valves and more.
Patients using the masks with magnets or anyone in close physical contact with mask magnets should keep them six inches away from implants or medical devices that could be impacted by magnetic interference.
