17M Philips CPAP, BiPAP masks recalled for “serious safety concerns” – KIRO 7 News Seattle

WASHINGTON — Medical device company Philips Respironics has recalled at least 17 million masks used with respirators designed to treat patients with sleep apnea and other respiratory conditions, federal state officials said this week. health.

>> Read more trending news

In a statement released on Tuesday, the US Food and Drug Administration said a “serious safety issue” with the magnets prompted the recall of the products, which are worn with bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) devices. Affected masks include Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask and 3100 NC/SP Therapeutic Mask, agency said.

“The recalled masks are worn by a person while using a BiPAP or CPAP machine and have magnets that connect the mask components to hold the device in place,” the statement said. “Magnets can potentially affect the function or cause movement of certain implanted metal medical devices, which could result in injury or death to the mask user or those close to the patient wearing the recalled mask, such as a bed partner. , which have such devices.”

The FDA said the magnets could cause problems with pacemakers, aneurysm clips, implantable cardioverter defibrillators, metal stents and other medical devices, WAFB-TV reported. Additionally, the recalled masks could affect patients and bystanders “who have metallic objects in their bodies, such as shrapnel or splinters in their eyes,” according to the FDA press release.

The FDA has recommended that patients who have — or sleep near people who have — medical devices or implanted objects “discontinue use of the recalled mask and switch to a non-magnetic mask if available.”

“You may continue to use the mask, if you or someone near you while using the recalled mask do not have any of the implanted metallic medical devices or metallic objects in the body listed above that could be affected by the magnets of the masks”, continues the agency.

Philips has received at least 14 reports of serious injuries related to the recalled masks, the FDA said. No deaths have been reported, according to the agency.

Comments are closed.