DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, Amara View Minimal Contact Full-Face Mask and Therapy Mask 3100 NC/SP
Published 23 November 2022
Product
Patient Interface devices (face and nasal masks) DreamWear Full Face Mask, DreamWisp Nasal Mask, Wisp and Wisp Youth Nasal Mask and Amara View Full Face Mask Multiple part numbers (see attached list) ARTGs 301663, 194980, 209222, 225674
Why it was recalled
The affected masks contain magnets which can potentially affect the functioning of implanted medical devices such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators, defibrillators, VP shunts, and neurostimulators used in and around the neck or any implanted medical device impacted by magnetic fields. Philips Respironics is updating the existing contraindications and warnings on the Instructions For Use (IFU) to strengthen the current labelling and warnings related to magnets.
Hazard
If the mask magnets are placed less than 6 inches (approx. 15.24 cm) away from a metallic implant or device, the magnets may cause the device to not function as intended. This can result in serious injuries. Possible impacts may include seizure, arrhythmia, irregular blood pressure, change in heartbeats and cognitive issues.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.