PHG - Philips recalls certain masks used with respiratory devices over safety issues

Philips ( NYSE: PHG ) has recalled certain masks used with some respiratory machines due to potential risk of injury.

The masks have magnets and should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body, Philips said in a Sept. 6 press release.

The U.S. Food and Drug Administration (FDA) said these masks can cause potential injuries or death when they interfere with certain implanted metallic medical devices and metallic objects in the body.

The FDA noted that it it was alerting that Philips Respironics, a unit of Philips, has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines.

The magnetic headgear clips are used to attach the headgear straps to the masks, according to the company.

Philips said that more than 17M masks containing magnetic clips have been distributed by its unit to date.

As of Aug. 30, 2022, Philips reported 14 injuries, including pacemaker interference and pacemaker failure leading to replacement, and 0 deaths related to the use of the masks, the FDA noted.

Philips added that these masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

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