On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA), Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia for the specific affected devices.
The Urgent Product Defect Correction informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. Additionally, the notification provides details of our repair and replacement program, to correct this issue as thoroughly as possible.
To implement the permanent corrective action, where possible, Philips will be contacting affected patients and customers with the relevant information on the next steps.