Urgent Product Defect Correction in Australia
Philips Sleep and Respiratory Care Devices
In July 2021, following consultation with the Therapeutic Goods Administration (TGA), Philips Australia and New Zealand announced an Urgent Product Defect Correction in Australia for specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
An update on our progress
Globally, we have remediated 99% of actionable* sleep therapy device registrations to date. *Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.
As the remediation of the ventilator devices continues, please visit the Ventilation page for news and updates.
In Australia, we continue to support patients with an affected device. As a first step, if your device is affected, please start the registration process here.
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.
Click here to view the Opt Out Notice from the Federal Court of Australia in the Philips Class Action. Please read the Opt Out Notice carefully. It has been published by order of the Court to inform class members about the Philips Class action and their rights and the steps group members need to take if you wish to opt out of the class action. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Please note that some people may have received a copy of the Notice by email or post which contained an incorrect email address for the return of any completed opt out forms in paragraph 7.4. The correct email address is vicreg@fedcourt.gov.au and that change has been made in the Notice that is accessible at the above link. If you have not received a copy of the Notice and would like to see it, you can find a copy by clicking the link above.
Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnoea devices or masks and should not be used.
Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Images may vary.
Not yet registered?
Resources from Philips Respironics
Further information in relation to the global recall and devices has been made available by the legal manufacturer, Philips RS North America LLC (Philips Respironics), a company based in the USA.
The following updates in relation to device testing have been released by Philips Respironics on this webpage:
This information has not been separately verified by Philips Electronics Australia Ltd.
Resources from Royal Philips
Further information in relation to the global recall has been made available by Koninklijke Philips N.V. (Royal Philips), a company based in the Netherlands.
The following updates in relation to the global recall and recent media articles have been released by Royal Philips on the below webpages:
This information has not been separately verified by Philips Electronics Australia Ltd.
At Philips, patient safety and quality are at the heart of everything we do
Questions and answers
The following products listed are affected by the correction:
CPAP and BiLevel PAP Devices
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers
(excluding Reworked CPAP and BiPAP Devices* with a label on the base showing Rev 15 or a higher number)
*Reworked CPAP and BiPAP Devices are new devices which have been reworked with new silicone sound abatement foam and a new internal air pathway and blower. While these Reworked CPAP and BiPAP Devices have a manufacturing date prior to 26 April 2021, they have never been used and are not affected by the correction. All Reworked CPAP and BiPAP Devices have a label on the base showing REV (short for revision) 15 or a higher number (refer example label above).
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30
(Emergency Use Authorization)
DreamStation ASV
Also known as DreamStation BiPAP autoSV
DreamStation AVAPS
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
SystemOne ASV4 (50 and 60 Series)
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
C Series S/T, AVAPS (50 and 60 Series)
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
OmniLab Advanced Plus
In-Lab Titration Device
Information for Trilogy 100 patients with a repaired 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.
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP A30
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
What products are not affected and why?
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.
