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


Philips Sleep and Respiratory Care Devices – Australia and New Zealand

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) 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.

 

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.

Not registered?

1800 009 579 in Australia or 0800 578 297 in New Zealand

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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.

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

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.

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