Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

Information for clinicians, all in one place

We remain committed to ensuring the safety and wellbeing of your patients and will continue to partner with you to help support them.

While there is more to be done, we are making steady progress. We ramped up production capacity and have devices available for those who need them. We are also continuing our extensive test and research program.

Your patients have several options for remediation which include payment, continue to wait for a new or refurbished device, or opt for an auto-adjusting CPAP.

If your patients chose an Auto-adjusting CPAP device from Philips Respironics, you may receive questions concerning their treatment to make sure that an auto-CPAP is appropriate for their condition.

Learn more about Auto-adjusting CPAP devices here

Your role in the remediation process

Read the FSN recall notification

(225.0KB)

Questions and answers

Find the latest clinical bulletins and information for you and your practice here ›

Visit our patient information page to discover the resources that we are providing to patients ›

May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients

The tests, conducted together with five independent, certified testing laboratories and assessed by third- party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.

Learn more

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

News and updates

Important updates for clinicians

Testing results for affected devices

May 16, 2023
Click here to learn more

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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 Clinician updates

Resources for Clinicians and Physicians

May 12, 2023
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Clinicians
Important information about patient prioritization

April 12, 2023
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Patients

Clinicians

Business customers
Tools and resources to support your patients

April 12, 2023
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Clinicians

Business customers
Dr. Jan Kimpen, Senior Medical Advisor, answers key questions from patients

February 13, 2023
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Patients

Clinicians

Business customers

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Questions and answers

General (8)

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.

Based on the comprehensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Please click here for the latest testing and research information.

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.

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 guidance for healthcare providers and patients remains unchanged. We are focused on making sure patients and their clinicians have all the information they need.

Further testing and analysis on other devices 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.

What is the status of the Trilogy 100/200 remediation?

Please visit the ventilation news and updates page for the latest status of the Trilogy 100/200 remediation.

Where can I find updates regarding patient safety?

In December 2022, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. You can read the press release here.

What is considered a “first generation DreamStation device”?

The testing information published in December 2022 was performed on the original DreamStation device and applies to DreamStation, DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, DreamStation BiPAP ASV, and E30 ventilator devices. It does not apply to DreamStation Go. [FOR WEB] Please scroll down to view photos of affected devices if you are unsure which device you currently use.

For clinicians (4)
For clinicians (4)
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.

Based on the comprehensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Please click here for the latest testing and research information.

Further testing and analysis on other devices is ongoing.

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.

This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products.

To read more about ongoing testing and research, please click here.

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.

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

Information for clinicians, all in one place

Find the latest clinical bulletins and information for you and your practice here ›

Visit our patient information page to discover the resources that we are providing to patients ›

May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients

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

News and updates

Testing results for affected devices

Ozone Cleaner Information

All Clinician updates

Resources for Clinicians and Physicians

Important information about patient prioritization

Tools and resources to support your patients

Dr. Jan Kimpen, Senior Medical Advisor, answers key questions from patients

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