Philips Recall Announcement and Information
The TGA is currently working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
The majority of the affected devices are in the first-generation DreamStation product family. A full risk assessment is underway including numbers supplied in Australia and on potential particulate and chemical exposure risks which will inform further advice to health professionals and consumers. TGA will continue to work with Phillips to ensure that comprehensive information is made available as quickly as possible through formal published announcements on the TGA website and from Phillips directly to customers
You can view the latest announcements from TGA regarding this matter via the link below:
Philips will soon update with a recall check and claim function through the link below once it has been approved by the regulatory body.
You can also use the link below to view the list of impacted machines and FAQs.
If you have any questions or concerns regarding your Philips device, please contact the Philips hotline: 1800 830 517
In the meantime, TGA has provided the following information for patients and users: For devices currently in use in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available. However, you are strongly encouraged to speak with your physician directly if you are concerned about a possible adverse event associated with using the devices.
Sove CPAP Clinic is committed to working with Philips to ensure our affected customers are properly communicated with and supported during this time and we endeavor to provide you with the most updated information and instructions as soon as we receive them from the manufacturer.
Thank you for your understanding.