The FDA has issued yet another safety communication concerning certain respiratory machines manufactured by Philips Respironics.
Previous Philips Respironics recalls
Last year, the FDA recalled certain ventilators, BiPAP, and CPAP machines made by Philips Respironics. Those machines contained polyester foam that could break down and be harmful if inhaled.
Just last month, the FDA announced the recall of respiratory BiPAP machines made by the same company due to contaminated plastic.
What is the latest recall about?
Philips Respironics is recalling masks used with certain BiPAP machines and CPAP machines. The masks have magnetic clips that attach the masks to headgear straps.
The manufacturer has discovered that the magnets can interfere with metal medical devices or metal objects in the body. Examples include pacemakers, metallic stents, aneurysm clips, denture attachments, and implanted defibrillators.
The mask magnets may interfere with the machine user’s implanted metal devices. The mask magnets may also interfere with metal devices implanted in a person near the machine user.
What happens if a magnet interferes with the metal?
The magnets may cause the medal devices to malfunction, which may be fatal. For example, if a pacemaker stops working, it may lead to a heart block or irregular heartbeat. Or they may cause the metal devices to move. This can lead to pressure on unintended body parts, which may be fatal.
What products are included in the recall?
The following models are being recalled:
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp and Wisp Youth Nasal Mask
- Therapy Mask 3100 NC/SP
The recalled masks can be used with other manufacturers’ BiPAP and CPAP machines as well.
What do I do if my device has been recalled?
- Stop using the mask and use a non-magnetic mask if available.
- Make sure the recalled mask is kept at least 6 inches away from anyone with a metal implant.
- Consult your doctor if you experience any adverse events.
- Consult your doctor to determine if your treatment should change.
The full FDA communication can be found here: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication | FDA
