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

See a list of details to help identify the product

Reason the product is 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.

The hazards to consumers

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 consumers should 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

Details to help identify the product

Supplier running the recall

Who sold the product

Hospital and Healthcare Services

Identifying product features

Where the product was sold

Nationally
International
Online

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2022/19641 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.