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 ›

Information for clinicians ›

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.

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, 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:

Please note that the Philips RS North America 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.

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

Not yet registered?

Check the affected device list

Register your device(s)

Questions and answers

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

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

General (10)

Why did Philips issue the global recall notification in June 2021?

Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices.

Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. Testing is ongoing and you can obtain further information about the testing and matters relating to the recall from the legal manufacturer, Philips RS North America LLC. Please note that information on that site is provided and verified by Philips RS North America LLC only.

The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration.

1) PE-PUR foam may degrade into particles which may enter the devices’ air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and

2) the PE-PUR foam may off-gas certain chemicals. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the device’s useful life.

Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. We thank you for your patience as we work to restore your trust.

*Voluntary recall notification in the US/field safety notice for the rest of the world.

What is the potential issue?

The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. This was initially identified as a potential risk to health. After careful analysis, Philips Respironics issued a Recall Notification in the US and a Field Safety Notice in other markets.

Based on the comprehensive testing and analysis that Philips Respironics have done over the past 18 months – working with five independent certified laboratories, third-party experts and physicians – Philips Respironics now have a complete set of results for the first-generation DreamStation devices. Please click here for the latest testing and research information.

By clicking the links above you are now accessing information of Philips RS North America LLC, the legal manufacturer. Information on that site is provided and verified by Philips RS North America LLC only.

We are sincerely apologetic for any disruption of care or inconvenience that you may have experienced. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. We thank you for your patience as we work to restore your trust.

What is the advice for patients and customers?

If you have not done so already, please click here to begin the device registration process.

Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions:

For patients using BiLevel PAP and CPAP devices:

Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.

For patients using life-sustaining mechanical ventilator devices:

Do not stop or alter your prescribed ventilator therapy. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter.

For patients using Trilogy 100, please click here for more information.

For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update

If you are a patient who has been affected by this correction, do not try to remove the foam from your device. Doing this could affect the prescribed therapy.

Which devices are affected?

The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices.
The affected products are identified in the tables below:

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)
Continuous Ventilator, Non-life Supporting	DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto

Mechanical Ventilators

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

Continuous Ventilator	Trilogy 100 Trilogy 200
Continuous Ventilator, Non-life Supporting	A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US)

What products are not affected and why?

Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. You can find the list of products that are not affected as part of the corrective action here.

Are there any recall updates regarding patient safety?

The guidance for healthcare providers and patients remains unchanged. We are focused on making sure patients and their clinicians have all the information they need.

Based on the comprehensive testing and analysis that Philips Respironics have done over the past 18 months – working with five independent certified laboratories, third-party experts and physicians - Philips Respironics now have a complete set of results for the first-generation DreamStation devices. Please click here for the latest testing and research information. By clicking the links above you are now accessing information of Philips RS North America LLC, the legal manufacturer. Information on that site is provided and verified by Philips RS North America LLC only.

Further testing and analysis on other devices is ongoing by Philips RS North America LLC, the legal manufacturer.

What devices have you already begun to repair/replace?

The correction program is now in progress for the following devices:
- DreamStation CPAP, Auto CPAP and Auto BiPAP
- DreamStation ASV
- DreamStation AVAPS
- System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series)
- System One ASV4 (50 and 60 Series)
- C Series S/T and AVAPS
- A-Series BiPAP (A40 and A30)
- DreamStation Go

With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available.

Where can I find information about the correction of Trilogy 100 devices?

Please visit the ventilation news and updates page for information on the Trilogy 100 correction.

Where can I find updates regarding patient safety?

Since July 2021 Philips Respironics, working with independent certified laboratories, third-party experts and physicians, has been conducting a comprehensive test and research program.

Please click here for the latest testing and research information from Philips Respironics. By clicking the link above you are now accessing information of Philips RS North America LLC, the legal manufacturer. Information on that site is provided and verified by Philips RS North America LLC only.

What is considered a “first generation DreamStation device”?

The testing information published by Philips Respironics in December 2022 was performed on the original DreamStation device and applies to DreamStation, DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, DreamStation BiPAP ASV, and E30 ventilator devices. It does not apply to DreamStation Go. Please scroll down to view photos of affected devices if you are unsure which device you currently use.

For patients (7)

How do I know if my device is affected?

The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices.
The affected products are identified in the tables below:

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)
Continuous Ventilator, Non-life Supporting	DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto

Mechanical Ventilators

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

Continuous Ventilator	Trilogy 100 Trilogy 200
Continuous Ventilator, Non-life Supporting	A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US)

If my device is affected, what do I do?

Please be assured that our teams are working 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.

Can I trust the new foam? How are you removing the old foam safely?

We know how important it is to feel confident that your therapy device is safe to use. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam.
If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. This could affect the prescribed therapy.

What happens after I register my device, and what do I do with my old device?

After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you.

When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips.

Once you receive your replacement device, you will need to return your old device. The return shipment for your old device is pre-paid so there is no charge to you.

Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device.

Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand.

Where do I direct questions about my replacement device?

For more information about your replacement device including video instructions click here.

For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider.

How long will it take to fix the issue?

Philips Australia expects to have completed the replacement program by the end of the first quarter of 2023 for the majority of devices where, by 28 February 2023, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. The device types are:

DreamStation CPAP, Auto CPAP and Auto BiPAP 
DreamStation ASV
DreamStation AVAPS
System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series)
System One ASV4 (50 and 60 Series)
C Series S/T and AVAPS
A-Series BiPAP (A40 and A30)
DreamStation Go

For the above devices registered after 28 February 2023, once Philips has received your device settings and confirmed your contact information, we currently expect that we will be able to send your replacement device to you within approximately 4 weeks. Please note that this is a projection based on the information presently available and may change.

Please note, the correction for Trilogy 100 is currently on hold. We are in touch with relevant customers and patients. For more information click here.

For further information please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1.

I have seen foam repair kits offered online at Amazon.com and elsewhere from third parties. Can I buy one and install it instead of returning my device?

No. These “repair kits” are not approved for use with Philips Respironics devices. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used.

For clinicians (3)
For clinicians (3)
Are there any steps that customers, patients, and/or users should take regarding this issue?

Patients who are concerned should check to see if their device is affected by the corrective action. The list of affected devices can be found here.

If their device is affected, they should start the registration process here. All patients who register their details will be provided with regular updates.

We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use.

Are you still taking new orders for affected products?

At this time, affected devices are on manufacturing and ship hold.

Are spare parts currently part of the ship hold?

Spare parts are not currently affected by the ship hold, though there may be some limited exceptions.

For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold.

Please visit the ventilation news and updates page for information on the Trilogy 100 correction.

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)

Continuous Ventilator, Non-life Supporting

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

Non-continuous Ventilator

System One 50 series

CPAPs, Auto CPAP, BiPAPs

System One 60 series

CPAPs, Auto CPAP, BiPAPs

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation GO

CPAP, Auto CPAP

If your device is affected...

Register your device

Back to top of the list

Mechanical Ventilators

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

Continuous Ventilator

Trilogy 100 Ventilator

Trilogy 200 Ventilator

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...

Register your device

Back to top of the list

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 202

BiPAP A40 EFL

BiPAP A40 Pro

Omnilab (original based on Harmony 2)

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

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 ›

Information for clinicians ›

Resources from Philips Respironics

Not yet registered?

Questions and answers

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Continuous Ventilator, Non-life Supporting

Noncontinuous Ventilator

Mechanical Ventilators

Continuous Ventilator

Continuous Ventilator, Non-life Supporting

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Continuous Ventilator, Non-life Supporting

Noncontinuous Ventilator

Mechanical Ventilators

Continuous Ventilator

Continuous Ventilator, Non-life Supporting

The following products listed are affected by the correction:

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation AVAPS

SystemOne ASV4 (50 and 60 Series)

C Series S/T, AVAPS (50 and 60 Series)

OmniLab Advanced Plus

Non-continuous Ventilator

System One 50 series

System One 60 series

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation GO CPAP, Auto CPAP

Mechanical Ventilators

Continuous Ventilator

Trilogy 100 Ventilator

Trilogy 200 Ventilator

Information for Trilogy 100 patients with a repaired device

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A30

What products are not affected and why?

DreamStation GO

CPAP, Auto CPAP