Medical Device Recall Information

Philips Respironics Sleep and Respiratory Care devices

Information for patients, all in one place

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

Patient safety is our top priority, and we are committed to supporting you and your care team throughout the remediation process.

Be sure to visit this page regularly for the most current and accurate information.

Thank you for your patience and continued trust.

Find out latest updates

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Read the FSN recall notification

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Questions and answers

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Support at every step of the way

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Affected device list

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Registered patients can also enter prioritization information. This information helps patients with the greatest needs receive their replacement device sooner.

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Return your affected device and set up your new device

When you receive your replacement device, it will include instructions on how to return your original device and how to set up your replacement.

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Learn more about the remediation process

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We’ve added new tools to our website to make it easier to complete important steps in the process in once place, including:

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Please note that the Philips Patient Portal is available in the US only.

Already registered?

We’ve added new tools to our website to make it easier to complete important steps in the process in once place, including:

Check your order status

Provide additional registration information

Check now

Please note that the Philips Patient Portal is available in the US only.

News and updates

Important updates for patients

2,200,000

repair kits and replacement devices produced to date globally

1,100,000

devices shipped in the US

*Market specific numbers as of April 20, 2022 and will be updated monthly.

Testing results for affected devices

April 25, 2022
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Important business customer update

Important clinician update

Important patient update
Ozone Cleaner Information

February 8, 2022
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Important business customer update

Important patient update

Important clinician update

All Patient updates

Understanding the recall process

March 8, 2022
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More :

Patients

Clinicians

Business customers
Important information about patient prioritization

April 22, 2022
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More :

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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Patients

Clinicians

Business customers
Important update to Philips US recall notification

November 16, 2021
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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 (17)

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.

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.

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 as they may be used with your replacement device.

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?

Philips Respironics continues to ship remediated devices and has increased production capacity to address the recall. We expect to continue to ship replacement devices throughout the remainder of 2022.

Please be assured that we are working hard to resolve the issue as quickly as possible. Once you are registered, we will share regular updates to make sure you are kept informed.

Should I stop using my device?

It is important that you do not stop using your device 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.

How long will it take to fix the issue?

We expect that we will have completed the repair and replacement program by the end of 2022 for the vast majority of patients.

Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. We will share regular updates with all those who have registered a device.

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.

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.

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. You do not need to register your replacement device.

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.

I've been told that I am considered "not matched" to a DME and therefore Philips RS is unable to send me my replacement device. How long will I have to wait?

As a patient, if you have registered your device, but it has not been matched to a DME provider, there may be several reasons that this has occurred. We are dedicated to working with you to come to a resolution. It is also important that your DME provider work with Philips RS to ensure that we have the information required to be able to send you your replacement device. Once Philips RS receives this information from your DME, we can continue to proceed with the remediation of your affected device. If you have a DME and have not already, please contact notify them that they need to register your affected device serial number so that we can match you to your DME and continue the process.

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

Not registered?

Support at every step of the way

Already registered?

Already registered?

News and updates

2,200,000

repair kits and replacement devices produced to date globally

1,100,000

devices shipped in the US

Testing results for affected devices

Ozone Cleaner Information

All Patient updates

Understanding the recall process

Important information about patient prioritization

Quick tips about the recall

Philips provides update on the test and research program

Important update to Philips US recall notification

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?

Dorma 400, 500 CPAP, Auto CPAP