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

Official notice

23 Nov 2022

Last checked

23 Nov 2022

Medium riskACCC

An official ACCC notice concerns 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. 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. Published 2022-11-23.

What to do now

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

Recall number

718aca28-ae2a-4234-b1e3-312c7a8bf2ab

Official notice

2022-11-23

The 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.

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Affected products

Product 1

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

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

medium

Recall details

Recall number

718aca28-ae2a-4234-b1e3-312c7a8bf2ab

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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