Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

3,000,000

repair kits and replacement devices produced to date globally

1,400,000

devices shipped in the US

*Market specific numbers as of July 22, 2022 and will be updated monthly.

Information for business customers, 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).

We recognize the importance of your relationship with your patients. You play a crucial role in supporting them through the remediation process. At Philips, we are committed to supporting you throughout the remediation and have a range of tools and resources to help.

Thank you for your patience as we work to restore your trust.

Not registered?

Read the FSN recall notification

(225.0KB)

Check the affected device list

Questions and answers

Tools and resources

Support line 877-907-7508

Support at every step of the way

Get the latest information and resources

Check the affected device list

Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device.

The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced.

Please visit the Philips Learning connection to learn more

Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice

Technical Project Manager Jan Bennik speaks about the test and research program

News and updates

Important updates for business customers

Testing results for affected devices

July 25, 2022
Click here to learn more

More :

Important business customer update

Important clinician update

Important patient update
Ozone Cleaner Information

February 8, 2022
Click here to learn more

More :

Important business customer update

Important patient update

Important clinician update

All Business Customer updates

Who’s who in the remediation

August 5, 2022
Click here to learn more

More :

Patients

Clinicians

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

June 28, 2022
Click here to learn more

More :

Patients

Clinicians

Business customers
Ventilation news and update

June 1, 2022
Click here to learn more

More :

Business customers
Replacement Trilogy Circuit Inspection and Cleaning Instructions

June 1, 2022
Click here to learn more

More :

Business customers

Read all

My Philips for Professionals

Philips business customers can access additional information and support resources by logging into My Philips for Professionals.

Questions and answers

General (9)

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.

In addition, we are beginning the rework of affected Trilogy 100/200 devices at Philips Service Centers and designated remanufacturing sites in many markets.

When will Philips begin remediation of Trilogy 100/200?

We acknowledge the need for customers and patients to begin the remediation of ventilators as quickly as possible. Philips is working to begin Trilogy remediation in most markets. Since we received conditional approval for Trilogy remediation from the FDA in March 2022, we have been working diligently to fulfill all of the appropriate conditions and ramping manufacturing capacity in order to ship repair kits and begin to rework affected devices. In many markets, we anticipate the remediation of affected Trilogy 100/200 devices to begin in June 2022.

In May 2022, the FDA updated their safety communication to provide information on Medical Device Reports (MDRs) related to the Philips Respironics recall. Where can I find more information on filed MDRs?

On May 24, Philips Respironics issued a press release that provides additional context and information on the filed MDRs. You can read the press release here.

Where can I find updates regarding patient safety?

On May 24, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. You can read the press release here.

For business customers (5)
For business customers (5)
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?

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

We understand that this is frustrating and concerning for 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.

Are you still taking new orders for affected products?

We are not taking new orders at this time, and we have stopped all new shipments temporarily, in order to support the field safety notice.

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?

Preventive maintenance for Trilogy has been paused until the new silicone foam is authorized and available.

The Trilogy, as well as the components containing PE-PUR foam, have all been placed on hold, for potential risks as outlined in the sound abatement foam recall 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals.

Trilogy service instructions require PM periods as outlined for the 24 months/10,000 blower hours as well as the blower replacement. During these preventative maintenance periods, the service requires replacement of the PE-PUR foam components. Therefore, PM service cannot be completed until we have authorization for the new foam design with Trilogy.

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 rep 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.

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.

Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

3,000,000

1,400,000

Information for business customers, all in one place

Not registered?

Support at every step of the way

Get the latest information and resources

Visit our patient information page

Visit our clinician information page

Learn more about the remediation process

Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device.

Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice

Technical Project Manager Jan Bennik speaks about the test and research program

News and updates

Testing results for affected devices

Ozone Cleaner Information

All Business Customer updates

Who’s who in the remediation

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

Ventilation news and update

Replacement Trilogy Circuit Inspection and Cleaning Instructions

My Philips for Professionals

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

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