Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

Information for patients

I registered my affected CPAP / BiPAP device but have not yet received my replacement device or financial payment

If you registered an affected CPAP / BiPAP device and are still waiting for your replacement, it is likely because we need important information or consent from you. Without this information, we are unable to ship your replacement CPAP / BiPAP device. Depending on your affected registered device, you may have alternative options.

Check the Patient Portal

Learn about my options

I need to learn how to set-up and use my replacement CPAP/BiPAP device ›

Sleep therapy device safety information

Read the FSN recall notification

(225.0KB)

Check the affected device list

Questions and answers

Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

Ozone Cleaner Information

Latest updates

Explained: The voluntary Philips Respironics sleep and respiratory care devices recall*

* This is a voluntary recall notification in the US and field safety notice in other countries

Learn more

Explained: The Philips Respironics Consent Decree

April 4, 2024

Learn more

All news and updates

What products are affected by this recall?

What products are affected by this recall?

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 ST, AVAPS

Also known as DreamStation BiPAP autoSV

DreamStation ST, AVAPS

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

SystemOne ASV4

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

C Series S/T, AVAPS

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, APAP, Auto CPAP

Dorma 400, 500 CPAP, Auto CPAP

(not marketed in US)

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Mechanical Ventilators

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

Continuous Ventilator

Trilogy 100 Ventilator

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)

A-Series BiPAP V30 Auto Ventilator

Also known as BiPAP V30 Auto Ventilator (A-Series)

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)

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What products are not affected by this recall and why?
What products are not affected by this recall 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

A-Series Pro and EFL

DreamStation 2

Omnilab (original based on Harmony 2)

Dorma 100, Dorma 200, & REMStar SE

V60 Ventilator

V60 Plus Ventilator

V680 Ventilator

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

General questions

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, we issued a Recall Notification in the US and a Field Safety Notice in other markets.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

Following ongoing communications, Philips Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. Philips Respironics is in discussions with the FDA on the details of further testing.

Is it safe to continue using my affected device?

The guidance for healthcare providers and patients remains unchanged since the initial recall announcement in June 2021.

It is important that you do not make any changes to your therapy without discussing with your doctor. Although you may feel anxious at the news of the recall, we encourage you to talk to your doctor about the right treatment for you. Please refer to the FDA’s guidance on continued use of affected devices.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

Following ongoing communications, Philips Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. Philips Respironics is in discussions with the FDA on the details of further testing.
Patient questions

Patient questions

What is the potential safety issue with the device?

The potential issue is with the foam in the device that is used to reduce sound and vibration. In some cases, this foam showed signs of degradation (damage) and chemical emissions. This is a potential risk to health.

The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). As a result, testing and assessments have been carried out.

Recent testing and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that the volatile organic compounds and particulate matter emissions related to foam degradation are within applicable safety limits and are unlikely to result in appreciable harm to health in patients. However, Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Testing and analysis related to the affected ventilators is ongoing. You can find the latest testing results here.

Following ongoing communications, Philips Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. Philips Respironics is in discussions with the FDA on the details of further testing.

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 recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam*. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them.

Silicone foam is commonly used across the CPAP industry. This silicone foam has met all applicable industry testing standards, including particulate and VOC emissions testing, and is authorized as part of our remediation. In addition, it has been extensively tested for Philips Respironics by multiple independent, certified laboratories in accordance with the applicable regulatory standards, and no safety issues have been identified. Philips Respironics is in discussions with the FDA on the details of further testing.

This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation.

When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly.

If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. This could affect the prescribed therapy and may void the warranty.

*Trilogy Evo devices provided as loaners do not contain the silicone foam or the affected PE-PUR foam.

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

Please note that registration for affected CPAP and BiPAP devices ended on December 31, 2024.

You can check the status of your replacement CPAP or BiPAP device, in the Patient Portal. Please note: The US Patient Portal will remain open until June 30, 2025. This means that effective July 1, 2025, patients will not be able to access the portal.

Before opening your replacement device package, unplug your affected device and disconnect all accessories. Be sure to place your mask, tubing and SD card aside.

When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics.

You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. After five minutes, press the therapy button to initiate air flow. Your prescription pressure should be delivered at this time.

With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. Using packing tape supplied, close your box, and seal it. Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Philips Respironics has pre-paid all shipping charges.

As part of our commitment to quality and patient safety, Philips Respironics is dedicated to removing product containing the affected sound abatement foam from the market. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871.

How long will I have to wait to receive my replacement device?

Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. If you registered an affected CPAP / BiPAP device and are still waiting for your replacement, it is likely because we need important information or consent from you. Without this information, we are unable to ship your replacement CPAP / BiPAP device. Depending on your affected registered device, you may have alternative options. Please check the Patient Portal to determine if we are awaiting information from you. Please note: The US Patient Portal will remain open until June 30, 2025. This means that effective July 1, 2025, patients will not be able to access the portal.

Will I be charged or billed for an unreturned unit?

We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice.

The replacement device I’ve received has the same model number as my affected device. Is this replacement device affected by the recall too?

No- the replacement device you have received is not affected by the recall/ field safety notice, because the foam in the device has been replaced with a new type of foam. During the recertification process for replacement devices, we do not change the device serial number or model number.

My replacement device isn’t working or I have questions about it. What do I do?

Your Durable Medical Equipment provider (DME) can best support your questions about setup and support of your replacement device. Please contact your DME directly. To find a DME in your area, please reach out to your physician or insurance provider.

For additional support please click here.

Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

Information for patients

I registered my affected CPAP / BiPAP device but have not yet received my replacement device or financial payment

I need to learn how to set-up and use my replacement CPAP/BiPAP device ›

Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

At Philips, patient safety and quality are at the heart of everything we do

Latest updates

Explained: The voluntary Philips Respironics sleep and respiratory care devices recall*

Explained: The Philips Respironics Consent Decree

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

Continuous Ventilator, Non-life Supporting

DreamStation ST, AVAPS

DreamStation ST, AVAPS

SystemOne ASV4

C Series S/T, AVAPS

OmniLab Advanced Plus

Non-continuous Ventilator

System One 50 series

System One 60 series

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation GO CPAP, APAP, Auto CPAP

Dorma 400, 500 ​CPAP, Auto CPAP

Mechanical Ventilators

Continuous Ventilator

Trilogy 100 Ventilator

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

A-Series BiPAP V30 Auto Ventilator

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A30

Dorma 400, 500 CPAP, Auto CPAP