Medical Device Recall Information

Philips Respironics Sleep and Respiratory Care devices

Information for patients, all in one place

We know that you are eager to find out when you’ll receive your replacement CPAP, BiPAP or Mechanical Ventilator device. We understand the profound impact this recall has had on you, and that for those who are waiting for a repaired or replaced device, this progress can’t come quickly enough.

One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. We are partnering with clinicians and business customers throughout this process to ensure we’re doing all we can to help you and your healthcare needs.

We will continue to provide regular updates to you through monthly emails.

Useful links

Read the FSN recall notification

(225.0KB)

Check the affected device list

Questions and answers

Register your
affected device ›

Already registered?
Check your status on the Patient Portal ›

Learn how to set-up and use your replacement device ›

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

December 2022 update on completed testing for first-generation DreamStation devices

Based on the extensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices.

Learn more

Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients

Jan Bennik, Head of Test and Research Program, explains the details behind the testing results

** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Philips Respironics’ guidance for healthcare providers and patients remains unchanged. Philips Respironics will continue with the remediation program.

News and updates

Important updates for patients

Ozone Cleaner Information

February 8, 2022
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Important business customer update

Important clinician update

Important patient update

All Patient updates

Who’s who in the remediation

August 5, 2022
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Patients

Clinicians

Business customers
Replacement device safety information

August 5, 2022
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Patients

Clinicians

Business customers
Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

June 28, 2022
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Patients

Clinicians

Business customers
Quick tips about the recall

December 23, 2021
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Patients

Clinicians

Business customers
Philips provides update on the test and research program

December 23, 2021
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More :

Patients

Clinicians

Business customers
Cleaning and inspection instructions for existing accessories

September 3, 2021
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More :

Patients

Clinicians

Business customers

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Questions and answers

General (6)

What is the issue?

The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. This is a potential risk to health. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets.
We are aware of the concerns raised by this information and we are sincerely apologetic for any disruption of care or inconvenience that may have been a result. Please be assured that we are doing all we can to resolve the issue 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.
Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows:

For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include:
Stopping use of an affected device
Using another similar device that is not part of the recall
Continuing to use an affected device, if a patient’s health care provider determines that the benefits outweigh the risks identified in the recall notification.
Using alternative treatments for sleep apnea.

For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including:
Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification.
Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution.
We strongly recommend that customers and patients do not use ozone-related cleaning products. Additionally, we remind both customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible.
We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process.
For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), 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 recall, do not try to remove the foam from your device. Doing this could affect the prescribed therapy and may void the warranty. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly.

Which devices are affected?

The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea 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 ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto

Mechanical Ventilators

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

Continuous Ventilator	Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use	A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto
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 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 here.

Are there any recall updates regarding patient safety?

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.

Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Further testing and analysis is ongoing.

What devices have you already begun to repair/replace?

In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices.
With regard to mechanical ventilators, Philips is deploying a permanent corrective action to address the issues described in the recall notification. As part of the remediation process, customers and patients will be provided with more information on the next steps to implement the permanent solution as it becomes available.

In the interim, in specific markets, a Trilogy Evo device can be made available for patients currently using affected Trilogy 100 and 200 devices. Please contact your Philips representative if you are in need of a loaner Trilogy Evo device for a patient. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged.

For patients (5)

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 apnea 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 ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto

Mechanical Ventilators

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

Continuous Ventilator	Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use	A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto
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?

We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. As a first step, if your device is affected, please start the registration process here.

What is the safety issue with the device?

The 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.
It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. Review of this assessment has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. This new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. Further testing and analysis is ongoing. Please note that it is important that you only use approved cleaning methods for our devices and masks, as unapproved cleaning methods such as ozone may contribute to foam degradation.

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.
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.

I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back

We understand that any change to your therapy device can feel significant. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use.
The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Both the DreamStation CPAP and DreamStation 2 CPAP Advanced include an identifiable Therapy ON button. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing.
As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. Please review the DreamStation 2 Setup and Use video for help on getting started.
U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit www.philips.com/ds2-replacement for more information.

The following products listed are affected by the recall notification / field safety notice:

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 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)

If your device is affected...

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)

If your device is affected...

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

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.

Medical Device Recall Information

Philips Respironics Sleep and Respiratory Care devices

Information for patients, all in one place

Useful links

Register your affected device ›

Already registered? Check your status on the Patient Portal ›

Learn how to set-up and use your replacement device ›

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

December 2022 update on completed testing for first-generation DreamStation devices

Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients

Jan Bennik, Head of Test and Research Program, explains the details behind the testing results

News and updates

Ozone Cleaner Information

All Patient updates

Who’s who in the remediation

Replacement device safety information

Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

Quick tips about the recall

Philips provides update on the test and research program

Cleaning and inspection instructions for existing accessories

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, Minimum Ventilatory Support, Facility Use

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, Minimum Ventilatory Support, Facility Use

Continuous Ventilator, Non-life Supporting

The following products listed are affected by the recall notification / field safety notice:

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

Continuous Ventilator, Non-life Supporting

DreamStation ASV

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

What products are not affected and why?

Register your
affected device ›

Already registered?
Check your status on the Patient Portal ›

Dorma 400, 500 CPAP, Auto CPAP