| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01171-1 |
| Product Name/Description |
DreamWear Full Face Mask, DreamWisp Nasal Mask, Wisp and Wisp Youth Nasal Mask and Amara View Full Face Mask
Multiple part numbers
ARTGs 301663, 194980, 209222, 225674 and 209222 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/10/2022 |
| Responsible Entity |
|
| Reason/Issue |
Philips electronics is updating existing contraindications and warnings of certain affected masks that contain magnets which can potentially affect the functioning of certain implanted medical devices, such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators, defibrillators, VP shunts, and certain neurostimulators used in and around the neck or any implanted medical device affected by magnets.
If the mask magnets are placed less than 6 inches (approx. 15.24 cm) away from a metallic implant or device the magnets may result in a serious injury like seizure, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats and cognitive issues.
The updated contraindications and warnings are to strengthen the current labelling and warnings related to magnets.
No Adverse events have been reported to date in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips Respironics is updating its existing contraindication and warning as outlined in the customer letter (will be provided to the impacted customers only by Philips).
Philips are also advising patients, household members, caregivers, and bed partners with a medical implant/device:
- Must ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from the medical implant(s)/device(s).
- Patients should stop using the affected mask if the implant/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. |
| Contact Information |
1800 830 517 - Respiratory care support - Philips |