Medical Device Recall Notification

Philips Respironics Sleep and Respiratory Care devices

Device registration and recall contact information

On June 14, 2021, Philips issued a recall notification for the United States for specific affected ventilation and sleep apnea devices. The notification informs patients, users and customers of potential impacts on patient health and clinical use related to this issue. Read below to learn more about the recall, determine if your device is impacted, and next steps to register your device.

If you use one of the affected devices, the recall notification advises patients and customers to take the following actions:

Icon Doctor

Continue life-sustaining ventilation prescribed therapy


Consult with your physician as soon as possible to determine appropriate next steps.
Icon Stop

Stop use of BiLevel PAP & CPAP sleep apnea devices

 

Consult with your physician to determine the benefits of continuing therapy and potential risks.

There is nothing we take more seriously than providing patients with high quality products that are safe and reliable. If an issue arises, we are proactive in communicating and addressing it as we work tirelessly towards a resolution.

What you need to do

 

Philips is committed to rectifying this issue through a robust and comprehensive repair and replacement program. We have established a claims processing and support center to assist you.

Icon Patient

Patients, Users, or Caregivers​

 

Philips has established a registration process that allows Patients, Users, or Caregivers​ to look up their device serial number and begin a claim if their unit is affected.

Icon Business

Durable Medical Equipment Providers, Distributors, or Medical Institutions​

 

Click the link below to begin our registration process. If you are in the United States, you will receive a letter by June 23, 2021 from Philips about this issue that contains log-in credentials for the registration website. If you are located outside of the United States, you will receive the letter shortly thereafter. If you do not receive this letter, please call the number below.

 

After registration, we will notify you with additonal information as it becomes available.

Icon Medical professional

Physicians and other medical care providers​

 

Click the link below for additional clinical details on the issue and other information to help you advise your patients who have been impacted.

What devices are affected by the recall notification / field safety notice?

 

The recall notification (U.S. only) / field safety notice (Outside of U.S.) provides customers with information on how to identify affected products.


Additionally, the device Instructions for Use provide product identification information to assist with this activity.


Products listed in this notification include:

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Icon Doctor

Continue life-sustaining ventilation prescribed therapy


Consult your physician as soon as possible to determine appropriate next steps.

Continuous Ventilator

Trilogy 100

Trilogy 100 Ventilator

Trilogy 200

Trilogy 200 Ventilator

Trilogy 200

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A 40/30

A-Series BiPAP Hybrid A30

Also known as ​BiPAP Hybrid A30​Ventilator​ (A-Series)​
(not marketed in US)

V30

A-Series BiPAP V30 Auto Ventilator

Also known as​ BiPAP V30 Auto​ Ventilator ​(A-Series)

Continuous Ventilator, Non-life Supporting

A 40/30

A-Series BiPAP A40

Also known as ​BiPAP A40​ Ventilator ​(A-Series)​
(not marketed in US)​​
A 40/30

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(not marketed in US)​​

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Icon Stop

Stop use of BiLevel PAP & CPAP sleep apnea devices

 

Consult with physicians to determine the benefits of continuing therapy and potential risks.

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

E30

(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​
DreamStation AVAPS

DreamStation ST, AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T
60 Series CPAP, ASV

SystemOne ASV4

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​
C Series AVAPS/ST

C Series S/T, AVAPS

Also known as​ System One BiPAP AVAPS (C-Series), ​System One BiPAP S/T (C-Series)​​​
OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

50 Series CPAP, ASV

System One 50 series

CPAPs, Auto CPAP, BiPAPs​
60 Series CPAP, ASV

System One 60 series

CPAPs, Auto CPAP, BiPAPs​
DreamStation CPAP

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO CPAP, APAP, Auto CPAP

Dorma 400, 500

Dorma 400, 500 ​CPAP, Auto CPAP

(not marketed in US)​

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
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • A-Series Pro and EFL
  • Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAPs
  • DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP
  • Omnilab and OmniLab Advanced Titration devices
  • V60 Ventilator
  • V60 Plus Ventilator
  • V680 Ventilator
  • REMStar SE and Sleep Easy CPAPs​
  • Dorma 100, Dorma 200 CPAPs (not marketed in US)​
  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

Questions and answers

Why is Philips issuing a recall notification?

On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.


At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.


As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.


The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.


At the time of the June 2021 recall / field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions. Philips continues to monitor complaints received following the recall / field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve. 


The notification advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 
  • For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.


Philips is recommending that customers and patients do not use ozone-related cleaning products. 


Additionally, Philips is reminding 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.


We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 


The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. 

 

Are affected devices safe for use? Should affected devices be removed from service?

The recall notification (U.S. only) / field safety notice (Outside of U.S.) advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices:
    Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 
  • For patients using life-sustaining mechanical ventilator devices:
    DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.


Philips is recommending that customers and patients do not use ozone-related cleaning products. 


Additionally, Philips is reminding 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.

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?

The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.


Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate.


In the event of exposure to degraded foam: 

 

  • The potential risks of degraded foam exposure include: 
    • Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. 
  • At the time of the issuance of the June 14, 2021 recall / field safety notice, Philips Respironics had received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also had received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.  

 

In the event of exposure to chemical emissions:

 

  • The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. 
  • At the time of the issuance of the June 14, 2021 recall / field safety notice, Philips had not received reports of patient impact or serious harm as a result of this issue.
When will the correction for this issue begin? How long will it take to address all affected devices?

The company will replace the current sound abatement foam with a new material that is not affected by this issue. 


At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 


Philips will provide further clarity on projected dates for implementation of the correction to begin when this information is available. 


The process for preparing the corrections indicated in the recall notification (U.S. only) / field safety notice (International Markets) has begun.


This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.


Philips is notifying regulatory agencies in the regions and countries where affected products are available. 


Our global repair and replacement program for affected devices is being implemented in accordance with appropriate regulatory requirements in each market, which may, in some markets, include review and/or authorization by the relevant regulatory agencies. 


We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction.

Are affected devices continuing to be manufactured and/or shipped?
At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues.
Is this a recall? Have regulatory authorities classified the severity of the recall?

The issuance of the notification is a recall in the U.S., and field safety notice in Outside of U.S., according to regulatory agency criteria.


This recall notification / field safety notice has been designated a Class I recall by both the U.S. Food and Drug Administration and Health Canada.

 

For more information regarding FDA recall classifications, please visit:

 

For the FDA's recommendations regarding this Class I recall, please visit:

How will Philips address this issue? Are affected devices being replaced and/or repaired? Are customers entitled to warranty replacement, repair, service or other mitigations?

We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 


As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.


The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  


Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. The new material will also replace the current sound abatement foam in future products.


Philips is recommending that customers and patients do not use ozone-related cleaning products. 


Additionally, Philips is reminding 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 company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. 


Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.


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 physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

Are there any steps that customers, patients, users and/or clinicians should take regarding this issue?

Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets).

 

The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
  • For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
  • Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets) website, www.philips.com/SRC-update.
    • The website provides current information on the status of the recall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues.
    • The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process.
    • Call 877-907-7508 if you cannot visit the website or do not have internet access.

 

The company has developed a comprehensive plan for this correction, and has already begun this process.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

 

Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

 

For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Call 877-907-7508 if you cannot visit the website or do not have internet access.

What is the cause of this issue? Was it a design, manufacture, supplier or other problem?
Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio.
How did this happen, and what is Philips doing to ensure it will not happen again?

Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. 


The products were developed according to the required standards and regulatory registrations at the time of initial release.  The Philips Quality Management System has been upgraded to reflect alignment with updated standards. 


The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.

What is meant by "high heat and humidity" being one of the causes of this issue?

Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature.

 

The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. 

 

This factor does not refer to heat and humidity generated by the device for patient use.

Do affected units exhibit features that customers / users should watch out for? Particles or other visible issues?
Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (Outside of U.S.). 
Can Philips replace products under warranty or repair devices under warranty?

Affected devices may be repaired under warranty. 


Philips will provide further information regarding warranty replacement procedures during this issue when it is available.  

In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Will existing patient devices that fail be replaced?

At this time, Philips is unable to set up new patients on affected devices. Philips may work with new patients to provide potential alternate devices.

 

Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care.

 

Philips CPAPs cannot be replaced during ship hold.

Is Philips certain that this issue is limited to the listed devices? Is there any possibility others are affected?

Analysis by Philips under the company's Quality Management System has reviewed and identified affected devices that were designed to incorporate the PE-PUR foam.

 

In accordance with the Philips Quality Management System, the company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which we operate.

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