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.
*Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.
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
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
Explained: The Philips Respironics Consent Decree April 4, 2024
Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice September 27, 2023
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.
www.RespironicsCPAP-ELSettlement.com or call 855-912-3432.
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 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting Also known as DreamStation BiPAP autoSV
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
Non-continuous Ventilator CPAPs, Auto CPAP, BiPAPs
CPAPs, Auto CPAP, BiPAPs
DreamStation CPAP, Auto CPAP, BiPAP
DreamStation GO CPAP, APAP, Auto CPAP
Dorma 400, 500 CPAP, Auto CPAP
If your device is affected...
Mechanical Ventilators All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers
Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use A-Series BiPAP Hybrid A30
Also known as BiPAP Hybrid A30Ventilator (A-Series)
A-Series BiPAP V30 AutoVentilator Also known as BiPAP V30 Auto Ventilator (A-Series)
Continuous Ventilator, Non-life Supporting Also known as BiPAP A40 Ventilator (A-Series)
Also known as BiPAP A30 Ventilator (A-Series)
If your device is affected...
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.
Omnilab(original based on Harmony 2)
Dorma 100, Dorma 200, & REMStar SE
All oxygen concentrators, respiratory drug delivery products, airway clearance products.
General questions 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 .
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
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+
SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto
Mechanical Ventilators
Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use A-Series BiPAP Hybrid A30 (not marketed in US)
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.
here .
What progress have you made with the remediation of affected devices?
Globally, we have remediated 99% of actionable* sleep therapy device registrations to date.
here for our latest progress.
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 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
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+
SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto
Mechanical Ventilators
Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use A-Series BiPAP Hybrid A30 (not marketed in US)
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.
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.
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 .
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.
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 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 .
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.
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.
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.
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.
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.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 .
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.
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 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.
FAQs
We send out regular email updates about the recall, and you can always check philips.com/src-update for the latest information. You'll also get emails from us with information about your replacement device status.
Can I get a refund for a Philips CPAP recall? ›
If you are a User who purchased, leased, rented or paid for (in whole or part) a Recalled Device and you have registered and returned your Recalled Device to Philips Respironics you are automatically eligible for a Device Payment Award and a $100 Device Return Award .
How do I know if my CPAP is on the recall list? ›
Each Philips device includes a serial number on the bottom label . The numbers, like other serial numbers, adhere to a set SN or S/N pattern. These numbers will help identify a CPAP machine in the list of recalled devices.
Which CPAP machines are causing health problems? ›
The specific CPAP machines causing cancer included:
Dorma 400/500 CPAP. DreamStation CPAP, Auto CPAP, BiPAP. DreamStation GO CPAP and APAP. DreamStation ASV. DreamStation SV/AVAPS. SystemOne Q Series.
Do I have to return my Philips CPAP machine? ›
Device Components & Accessoriesmust be returned to Philips as soon as possible so that the old foam can be removed and replaced with silicone foam as part of the recall remediation plan.
What are the symptoms of the Philips CPAP lawsuit? ›
Symptoms of CPAP Recall Injury
Headache. Airway irritation. Sinus pressure. Persistent cough. Chest pressure. Skin, eye, or respiratory tract irritation. Headache. Inflammation.
How much is the CPAP lawsuit worth? ›
Philips agreed to a $1.1 billion settlement over CPAP and ventilator machines.
How can I check if I have a recall? ›
Visit NHTSA.gov/recalls. Select your state. Enter your vehicle's license plate number. Search to find out if your vehicle is subject to an open safety recall .
How much is the device payment award for Respironics? ›
“Under the terms of the settlement agreement, there are set payments ranging from $55.63 to $1,552.25 per recalled device … for device payment awards, and $100 per recalled device for device return awards to users.
Who qualifies for a CPAP lawsuit? ›
You may be eligible to file a Philips CPAP lawsuit if you or a loved one: Used a Philips Respironics CPAP, BiPAP, or ventilator machine . Received a recall notice for the machine. Suffered cancer or lung injuries linked to PE-PUR foam.
If you use a recalled CPAP or BiPAP machine, it's important to contact your doctor immediately to discuss what you should do. Depending on your needs and circ*mstances, your doctor may recommend that you immediately stop using your device or that you continue using it until you acquire a suitable replacement .
Which Philips CPAP models are recalled? ›
How Many Philips CPAP Machines Are Part of the Recall?
C-Series ASV. C-Series S/T and AVAPS. DreamStation ASV. DreamStation ST, AVAPS. E30. Garbin Plus, Aeris, LifeVent. OmniLab Advanced+ SystemOne ASV4.
How serious is the DreamStation recall? ›
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death .
What is the phone number for the Philips Respironics recall? ›
For further information about your current status, please log into the portal or call 877-907-7508 .
Is DreamStation 2 affected by recall? ›
Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine .
Is Philips no longer selling CPAP machines? ›
Reeling from one of the most catastrophic recalls in decades, Philips Respironics said it will stop selling sleep apnea machines and other respiratory devices in the United States under a settlement with the federal government that will all but end the company's reign as one of the top makers of breathing machines in ...
What is the Philips sleep apnea machine scandal? ›
Millions of CPAP sleep apnea machines made by the medical device maker Philips and a subsidiary were found to have a dangerous problem, triggering consumer lawsuits and a massive recall in 2021. Now, Philips has reached a $1.1 billion deal to settle claims from people who say they were injured.
What is the latest update on the Philips CPAP lawsuit? ›
Latest Updates: Philips Respironics reached a $1.1 billion settlement over CPAP lawsuits on April 29, 2024 . Of that, $1.075 billion would go toward personal injury claims that its devices caused serious complications or death.
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