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?

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.

Additional information for…

Patient

Visit our patient information page

Clinician

Visit our clinician information page

Questions and answers

General (4)

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 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.

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

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.

For patients (3)

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.

For business customers (2)
For business customers (2)
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.
For clinicians (2)
For clinicians (2)
What are you doing to fix the issue?

To resolve this situation as quickly as we can, we are doing the following:

Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices.

Updating everyone on what they need to know and do, and to participate in the corrective action.

Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices.

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.

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

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 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.

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

Philips Sleep and Respiratory Care Devices – Australia and New Zealand

Not registered?

Additional information for…

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

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