Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand)


Philips Sleep and Respiratory Care Devices – Australia and New Zealand

Information for patients, all in one place


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.

Patient safety is our top priority, and we are committed to supporting you and your care team throughout the correction process. Be sure to visit this page regularly for the most current and accurate information. Thank you for your patience and continued trust.

If you have questions about the correction process or need additional support once you have received your replacement device, please visit our Contact and Support page.

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.

Stop icon

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.

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:

Please note that the Philips Respironics website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia and New Zealand.

 

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:

Please note that the Royal Philips website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia and New Zealand.

This information has not been separately verified by Philips Electronics Australia Ltd.

Support at every step of the way

Support line 1800 009 579 in Australia or 0800 578 297 in New Zealand​

Refer to instructions provided with your corrected device. If you are in New Zealand, click on this link.

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

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 Emergency Use Authorization

E30

(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV image

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​

DreamStation ST, AVAPS

DreamStation AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T

SystemOne ASV4

SystemOne ASV4 (50 and 60 Series)

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​

C Series ST, AVAPS

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(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

50 Series CPAP, ASV

System One 50 series

CPAPs, Auto CPAP, BiPAPs​

60 Series CPAP, ASV

System One 60 series

CPAPs, Auto CPAP, BiPAPs​

DreamStation CPAP

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO
CPAP, Auto CPAP

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100

Trilogy 100 Ventilator

Trilogy 200

Trilogy 200 Ventilator

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A40

Also known as ​BiPAP A40​ Ventilator ​(A-Series)​
(not marketed in US)​​

A-Series BiPAP A30

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(not marketed in US)​​

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.

  • Trilogy Evo

  • M-Series

  • Trilogy Evo OBM

  • Trilogy EV300

  • Trilogy 202

  • BiPAP A40 EFL

  • BiPAP A40 Pro

  • Omnilab (original based on Harmony 2)

  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

You are about to visit a Philips global content page

Continue

You are about to visit a Philips global content page

Continue

Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox.