Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices (2024)

Philips Respironics Sleep and Respiratory Care devices

In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).

We are focused on delivering the best care possible, while supporting patients, customers and clinicians throughout the remediation process.

Information for patients›

Information for business customers›

Information for clinicians ›

An update on our progress

Globally, we have remediated 99% of actionable* sleep therapy device registrations to date.

As the remediation of the ventilator devices continues, Philips Respironics will be communicating with Durable Medical Equipment providers (DMEs) directly throughout the process. If you are a patient or caregiver with an affected Philips Respironics ventilation device, you do not need to take any action. All ventilation remediation will be handled via your DME.

Learn more

*Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.

Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices (4)

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

Resolution of Philips Respironics litigation

For more information on the personal injury settlement, please visit RespironicsPISettlement.com, call +1 (888) 735-6048, or email SettlementAdministrator@RespironicsPISettlement.com.

For more information on the medical monitoring settlement, please visit RespironicsMedicalAdvancementProgram.com.

Resolution of US economic loss litigation reached

Philips has reached an agreement, subject to final Court approval, to resolve all economic loss claims brought by private plaintiffs in the United States related to the Philips Respironics voluntary recall of certain sleep and respiratory care devices.

All related inquiries should be directed to the third-party Settlement Administrator, Angeion Group. For more information, please visit www.RespironicsCPAP-ELSettlement.com or call 855-912-3432.

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

See Also
Focused Exam: Pediatric GAS Pharyngitis | Completed | Shadow Health Focused Exam: Pediatric GAS Pharyngitis, Community-Acquired Pneumonia, Schizophrenia, COPD and Anti-asthmatics Concept Lab Case Study, Cough Subjective Data, abdominal Objective Data Collection, Esther Park Shadow Health Assessment...Completed Shadow Heal

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...

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

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 AutoVentilator

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-SeriesBiPAP 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 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

DreamStation2

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

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.

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)

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.

What progress have you made with the remediation of affected devices?

Globally, we have remediated 99% of actionable* sleep therapy device registrations to date.

Please click here for our latest progress.

*Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.

Please visit the ventilation news and updates page for the latest status of ventilation remediation.

What is considered a “first generation DreamStation device”?

DreamStation, DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, DreamStation BiPAP ASV, and E30 ventilator devices are considered “first generation DreamStation”. Please scroll down to view photos of affected devices if you are unsure which device you currently use.

Patient questions

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?

As a first step, if your device is affected, please start the registration process here.

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.

If you are a patient or caregiver with an affected Philips Respironics ventilation device, you do not need to take any action at this time.

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.

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.

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.

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.

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.

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

After you have registered your affected device, we will confirm your information by email prior to shipment and prepare to send your replacement. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications.To check the status of your replacement CPAP or BiPAP device, please be sure to visit the Patient 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.

Owners or users of DreamStation 1 devices who wish to preserve their units for purposes of a lawsuit have the option of requesting preservation, either by Philips Respironics or by the user, through the Preservation Registry established by Philips Respironics. More information and instructions on how to register for preservation may be found at: https://www.mdl3014preservationregistry.com.

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.

Once you are registered, we will share regular updates to make sure you are kept informed.

How long will it take to fix the issue?

Please be sure to check philips.com/src-update for the latest information on remediation progress.

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 approved for use by the FDA. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used.

As part of the remediation, we are offering repair or replacement of affected devices free of charge. We do not offer repair kits for sale, nor would we authorize third parties to do so.

Devices affected by the recall / field safety notice must be serviced only by qualified technicians. They do not include user serviceable parts. Attempts to remove or change the sound abatement foam may render the device permanently inoperative and create health hazards.

Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. The latest information regarding this action can be found at our publicly available web site: https://www.philips.com/src-update

What are you doing to resolve the issue?

We are producing and shipping similar CPAP, BiLevel PAP and Mechanical Ventilator platforms with a different design. 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 different, silicone foam.

Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. We also continue to partner with scientific and medical experts as part of our commitment to quality and patient safety.

Please click here for more information on the steps we take to ensure the safety of your replacement CPAP or BiPAP device.

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.

If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at https://www.mdl3014preservationregistry.com, Philips will not charge the user’s DME supplier for the cost of the replacement device. However, if the user is not in the Preservation Registry and fails to return his or her unit, then Philips may charge the user’s DME supplier for the cost of the replacement device.

What happens when Philips receives recalled DreamStation devices?

As soon as we receive the device, we replace the sound abatement foam and associated air pathway blower with brand new parts. This replacement reinstates the two-year warranty.

We then thoroughly clean and decontaminate the device, update the firmware, test, and repackage it with a “recertified” sticker to show that it is ready for use. As part of our commitment to quality and patient safety, Philips 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.

Please click here for more information on the steps we take to ensure the safety of your replacement CPAP or BiPAP device.

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.

I’ve received my replacement device. Why can’t I register it on the recall registration site?

Only devices affected by the recall/ field safety notice must be registered with Philips Respironics. You do not need to register your replacement device.

While replacement devices should not be added to the recall registry, patients wishing to keep their personal and product information up to date can create an account at My Philips.

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

Please contact Patient Recall Support Team (833-262-1871). They can help you if you have questions about how to use your replacement device and can troubleshoot and document issues you may be having.

Business customer questions
Business customer questions
What is the cause of the issue?

Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio.

How long will it take to fix the issue?

Globally, we have remediated 99% of actionable* sleep therapy device registrations to date. Please click here for our latest progress.

*Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.

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 be sure to check philips.com/src-update for the latest information on remediation progress.

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 are on hold.

When can Trilogy Preventative Maintenance be completed?

For the latest information on remediation of Trilogy 100/200 please click here to visit our ventilation news and updates page.
Clinician questions
Clinician 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.

What is the risk for patients?

At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Out of an abundance of caution, a reasonable worst-case scenario was considered. At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. Philips Respironics did not have conclusive data indicating that exposure to the particulates or emitted chemicals would lead to cancer.

Since then, together with five independent, certified testing laboratories in the US and Europe and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds. This also includes an in-depth review and re-assessment of data and toxicological risk-assessments prior to June 2021.

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.

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 so they understand the situation and know what they need to do, starting with the registration of the affected devices.

Frequently updating everyone on what they need to know and do, including updates on our improved processes.

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. 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, as they are recommended to be replaced after five years of use.

Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices (2024)

Philips Respironics Sleep and Respiratory Care devices

An update on our progress

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

Latest updates

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

Explained: The Philips Respironics Consent Decree

Resolution of Philips Respironics litigation

Resolution of US economic loss litigation reached

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Continuous Ventilator, Non-life Supporting

DreamStation ST, AVAPS

DreamStation ST, AVAPS

Non-continuous Ventilator

Mechanical Ventilators

Continuous Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP V30 AutoVentilator

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-SeriesBiPAP A30

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

References