News & Announcement

10/20/2022

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

Philips Respironics (Philips) is recalling certain Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks due to a serious safety concern. The recalled masks have magnetic headgear clips to hold them in place. The magnets can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body. Learn more. 


09/14/2022

Philips Respironics issues statement on masks with magnetic headgear clips

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices 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. Learn more.


09/14/2022

ResMed issues statement on masks with magnetic headgear clips

We are aware of the September 6, 2022, recall of certain Philips masks due to a safety issue with magnets that may affect some medical devices in or on a patient. ResMed is carefully reviewing the issues outlined in the FDA’s recall report, as we do with any relevant regulatory activity in the market.

We believe our (ResMed) masks are safe to use. While some ResMed masks use magnets in the lower headgear straps and the frame to assist with ease of closure and a secure fit, these masks contain magnets designed to a strength below the guidance from the International Commission of Non-Ionizing Radiation Protection (ICNIRP) for use of magnets in this setting, and ResMed masks provide instructions to users about the use of magnets in proximity to other medical devices. We will consider whether additional work is needed to further demonstrate the continuing safety of our masks that use magnets.

ResMed continually evaluates our products against applicable regulatory standards, industry guidance, safety standards, and good clinical practice, as they develop.