A notice from Phillips Electronics Australia Ltd.
Following consultation with the TGA, is undertaking a product defect correction for the 14 sleep and respiratory care devices they manufacture. This is in response to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these goods.
Philips has identified that the foam used in the blower boxes of their continuous and non-continuous ventilators may degrade into particles, which may enter the devices’ air pathway and be ingested or inhaled by the user, and release certain chemicals as gases. The foam may degrade more quickly if the device is cleaned using unapproved cleaning methods, such as ozone gas products.
Where possible, Philips will replace the sound abatement foam in affected devices. If this is not possible, a replacement device will be provided.
A patient-specific risk assessment may be needed to determine whether the benefits of continuing therapy outweighs the risks identified.
For more information about the recall please visit here https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-devices-and-mechanical-ventilators
UFS Pharmacies understand that the current CPAP and Bi-Level PAP device recall will cause some distress and discomfort to patients. We are currently working with the appropriate authorities to ensure that our patients health care is at the front of mind with little disruption.
Current UFS Pharmacies Sleep Apnoea patients will be contacted directly by 16 July 2021 with information and the relevant next steps.
We thank you for your patience as we continue to support you.
Updated 8 July 2021