Philips Amara View

2022: Recall of defective breathing masks

In early September 2022, Philips Responics warns users of some masks for CPAP therapy or two-level PAP therapy with magnetic clips or headband straps that these devices should not be used by patients and family members who have metal implanted devices or metal objects.

According to Philips, more than 17 million masks that contain magnetic clips or straps for fixing the headgear fall under the recall. Recalled products include the Amara View, DreamWisp, DreamWear, Wisp, Wisp Youth and Therapy Mask 3100 models.

Philips Amara View

The latter case came to light in early September 2022, when Philips and the FDA alerted users of their CPAP and BiPAP machines, as well as their caregivers and health professionals, to the potential health risk associated with magnets embedded in some of the masks used with those machines.

Magnets in these masks can interfere with implanted medical devices, including pacemakers, neurostimulators, metal stents, eye implants, aneurysm clips and more, which can be fatal, according to the FDA. Due to the force of the magnetic field, they can interfere with devices located at least six inches away.

Philips said that as of August 30, 2022, Philips Responics received 14 messages linking implant malfunctions to mask magnets. These incidents include device problems such as interference and pacemaker malfunctions and unplanned discharges and defibrillators disconnections, which in turn led to health problems such as arrhythmia, seizures, irregular blood pressure and cognitive problems.

Safety concerns led Philips to issue updated instructions and markings for all its masks for CPAP and BiPAP devices containing magnetic clips and straps. The new warning draws attention to possible magnetic interference and indicates that the presence of any metal implants, both in the mask user himself and in family members, carers and bed partners in the immediate vicinity of him, is a special contraindication for the use of masks.

Instead, affected users should consult their medical professionals and, if possible, switch to a non-magnetic mask. Doctors, meanwhile, should no longer prescribe the use of magnetic masks to patients who may come into close contact with metal implants. While the recall of magnetic masks is not directly related to the June 2021 recall of Philips masks, which is related to the possible destruction of polyester foam embedded in millions of breathing support devices, there is some overlap in the products affected by each recall.

As Jeff Schuren, MD, director of the FDA's Center for Instrumentation and Radiological Health, noted in a post, this latest recall raises additional safety concerns about both Philips devices already under recall and other devices.

Patients with questions can contact Philips Responics customer service at 1-800-345-6443 for more information on non-magnetic mask options. Patients can also contact their durable medical device (DME) provider, which supplied masks affected by this notice.^[1]

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