Medical Device Field Safety Notice (outside of U.S.)

Philips Respironics Sleep and Respiratory Care devices

FSN 2021-05-A & FSN 2021-06-A

Information for clinicians

We are fully committed to partnering with you to support your patients.

We completed the test and research program for affected CPAP and BiPAP devices, and testing on ventilation devices continues. Please visit this page for the latest results.

Due to the complexities of the remediation of ventilation devices, these devices will remain on a separate timeline from CPAP and BiPAP devices.

Resources

Field Safety Notice homepage

Questions and answers

Resources for Clinicians and Doctors

Latest updates

The latest information for you and your practice

Our clinical bulletins have been created to help update physicians on recent developments as well as provide a status update on remediation efforts.

Learn more

July 2023 latest results and conclusions for sleep therapy devices related to the impact of ozone cleaning shows no appreciable harm to health in patients

Philips Respironics completed the analyses for System One and DreamStation Go sleep therapy devices indicating that the volatile organic compounds (VOCs) and the particulate matter (PM) emissions related to foam degradation are within the appliable safety limits. Additional visual assessments have been performed and confirm the low prevalence of significant foam degradation.

Read the press release

Read the patient dedicated update

View/download the full report (683.0KB)

A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care

We are transforming our processes and the way we operate so we can deliver what matters most to our patients – safe and effective therapy.

David Ferguson

David Ferguson, Business Leader, Sleep & Respiratory Care, joined Philips in March 2021. Since then, he has led the organization through the voluntary field safety notice of certain CPAP, BiPAP and Mechanical Ventilator devices. With the comprehensive test and research program for affected CPAP/BiPAP sleep therapy devices¹ now complete, we asked him about what’s changed since the start of the field safety notice, what the test results mean for patients, and what to expect from Philips Respironics in the future.

1. First-generation DreamStation, System One and DreamStation Go devices

Learn more

All news and updates

How are we supporting your patients?

Learn about the Field Safety Notice and register their affected device

Read the Field Safety Notice for CPAP and BiPAP (FSN 2021-06-A)

(111.0KB)

Read the Field Safety Notice for ventilators (FSN 2021-05-A)

(111.0KB)

Check the affected device list

Questions and answers

Support line 0800 249 4578 (UK) or (0044) 20 8089 3822 (outside of UK)

Check the steps Philips is taking to ensure safety and confidence

Philips is taking steps to ensure the replacement devices are safe to use so patients can be confident in their new devices.

Check the steps here (295.0KB)

Update for patients on Field Safety Notice

Download the patient newsletter - November 2022 (119.0KB)

Download the patient newsletter - August 2022 (141.0KB)

Learn more about their replacement device

Learn more about specific replacement devices

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

Questions and answers

General (6)

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 Authorisation)
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 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 authorised 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.

In August 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?

In February 2023, 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?

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 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 Authorisation)
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.

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.

Further testing and analysis on other devices is ongoing.

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 affected 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 authorised 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 field safety notice, 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 colour 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.

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.

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.

We do not offer repair kits for sale, nor would we authorize third parties to do so.

Devices affected by the 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 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: 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.

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 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.

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?

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?

For the latest information on remediation of Trilogy 100/200 please click here to visit our ventilation news and updates page.
For clinicians (5)
For clinicians (5)
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 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 Authorisation)

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 Field Safety Notice (outside of U.S.)

Philips Respironics Sleep and Respiratory Care devices

Information for clinicians

Resources

Latest updates

The latest information for you and your practice

July 2023 latest results and conclusions for sleep therapy devices related to the impact of ozone cleaning shows no appreciable harm to health in patients

A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care

How are we supporting your patients?

Learn about the Field Safety Notice and register their affected device

Check the steps Philips is taking to ensure safety and confidence

Update for patients on Field Safety Notice

Learn more about their replacement device

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

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 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