On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
Our teams have been and continue to work on a comprehensive correction program to support patients with an affected device. As a first step, if your device is affected, please start the registration process here.
As we continue to work through the correction, we assure you that we are fully committed to supporting all patients to complete correction efforts.
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.
Further information in relation to the global recall and devices has been made available by the legal manufacturer, Philips RS North America LLC, a company based in the USA.
The following updates in relation to device testing have been released by Philips RS North America on this webpage:
This information has not been separately verified by Philips Electronics Australia Ltd.
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
There was an Alert issued to affected patients in November 2022, Product Defect Alert RC‐2022‐RN‐01396‐1. This Alert was related only to Trilogy 100 ventilators that were repaired.
Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms.
If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either ‘Low Inspiratory Pressure’ or ‘Circuit Disconnect’.
Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. If your ventilator is alarming with a High Priority alarm, you must do the following:
1. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilator’s operation. Always ensure you are being taken care of, i.e. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. See ‘Ventilator Alarms’ on pages 2 – 4 of your Trilogy 100 Instructions for Use. Follow those instructions. 3. If you have a secondary back up device, switch over to that device. 4. Contact your clinical care team to determine if a loan device is required. Philips Australia will work with your clinical care team to arrange a loan device, where required.
For more information click here.
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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