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. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. We thank you for your patience as we work to restore your trust. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you.
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) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices.
Also known as DreamStation BiPAP autoSV
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
In-Lab Titration Device
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
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