Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices

Agency remains committed to updating public about Philips recalled devices

Moment, theU.S. Food and Drug Administration is waking cases, caregivers and health care providers that Philips Respironics( Philips) has recalled certain masks used with bilevel positive airway pressure( also known as Bilevel PAP, BiPAP or BPAP) machines and nonstop positive airway pressure( CPAP) machines due to a serious safety concern. further than 17 million masks are impacted by this recall. BiPAP and CPAP machines help people with obstructive sleep apnea, respiratory insufficiency or respiratory failure — health conditions that beget pauses in breathing during sleep.

What you need to know
The recalled masks are worn by a person when using a BiPAP or CPAP machine and have attractions that connect the mask factors to hold the device in place.
The attractions can potentially affect the functioning of or beget movement of certain implanted metallic medical bias, which could affect in injury or death to the mask stoner or people near the case wearing the recalled mask, similar as a bed mate, who have similar bias. Medical bias that could potentially be affected by these attractions include brain stents, aneurysm clips, leaders, implantable cardioverter defibrillators, ventriculoperitoneal shunts, optical implants, glamorous denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by attractions.
The attractions could also affect mask druggies who have metallic objects in their body, similar as shrapnel or slivers in their eyes, including people near the case wearing the affected mask, similar as a bed mate.
Five mask types are affected by this recall the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks.
To date, Philips reported 14 serious injuries, including trendsetter failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks. The FDA is furnishing recommendations in a safety communication for cases, caregivers and health care providers concerning use of the recalled masks with attractions, which cases may be using with Philips BiPAP and CPAP machines or those of other manufacturers.
“ This rearmost recall raises farther safety enterprises both for Philips bias formerly subject to a recall, as well as fresh bias, ” said Jeff Shuren,M.D.,J.D., director of the FDA’s Center for bias and Radiological Health. “ We explosively encourage providers and at- threat cases to review this important safety information and follow our recommended conduct to reduce the eventuality for detriment from these products. ”

This recall isn’t associated with the polyester- grounded polyurethane( PE- PUR) froth issue for certain ventilators, BiPAP machines and CPAP machines recalled in June 2021. still, this recall affects masks used with some of the bias that were recalled in June 2021.

The FDA is committed to icing the public is kept informed of any fresh issues regarding these recalled masks and other developments involving the previous recalls of Philips ventilators, CPAP and BiPAP machines. The agency will continue to give updates when available.

Affiliated Information
FDA Safety Communication Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Attractions That May Affect Certain Medical bias
Letter to Health Care Providers Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Attractions That May Affect Certain Medical bias
FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

The FDA, an agency within theU.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of mortal and veterinary medicines, vaccines and other natural products for mortal use, and medical bias. The agency also is responsible for the safety and security of our nation’s food force, cosmetics, salutary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source link:https://www.fda.gov/