PRA number
Published date
Product description
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
What are the defects?
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.
What are the hazards?
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.
What should consumers do?
Consumers should read and follow the updated warnings and Instructions For Use (IFU) and take appropriate action:
Patients, Household Members, Caregivers and Bed Partners with a medical implant and/or device(s):
- Must ensure the mask is kept at least 6 inches (approximately 15.24cm) away from the medical implant(s) and/or device(s)
- Patients should stop using the affected mask if the implant and/or medical device is contraindicated against the mask magnets.
- Patients should consult their physician immediately to determine if another mask can be used for their therapy and in the interim, switch to a non-magnetic mask if available, for continued therapy.
- Patients should properly dispose of the mask that has magnets after an alternative is obtained.
- If patients do not have implanted medical devices, or metallic splinters in their eyes, then no action related to patients is needed.
If you are affected or need further information, please contact the Philips Sleep and Respiratory Care hotline on 180 830 517 to organise a suitable remediation which may include a replacement mask or clips to replace the magnets.
For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01171-1
Traders who sold this product
Hospital and Healthcare Services
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.