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 HSE patients


This page covers HSE patients that have received their device through a healthcare provider, if you have purchased your device directly yourself, please click here to go to the page that covers your device.


Patient safety is our top priority. We are committed to completing the remediation for all affected patients to make sure you receive safe and effective therapy. 

We know that each situation is unique depending on your affected device and personal situation. If you have questions about the remediation process or need any additional support once you have received your replacement device, please contact your home care provider or your clinician.

Process illustration

We created a guide outlining each step of the remediation process, so you can understand how we’re handling the recall and what to expect.

Understand the steps we take to ensure the safety of your replacement CPAP or BiPAP device


While we work to provide replacement devices as quickly as possible, we want to share the steps we are taking to ensure your First Generation DreamStation replacement device is safe to use so you can be confident in your new device.

Philips Respironics first-generation replacement device information
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Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

Support at every step of the way

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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.

Update for patients on Field Safety Notice

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Learn more about your replacement device

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Return your affected device

Your healthcare provider will be in contact when your replacement device is available, also information regarding what to do with your affected device.

News and updates    

Important updates for patients

December 21, 2022 - Update on completed testing for first-generation DreamStation devices

Based on the extensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices.

Jan Kimpen

Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients

Jan Bennik

Jan Bennik, Head of Test and Research Program, explains the details behind the testing results

** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Philips Respironics’ guidance for healthcare providers and patients remains unchanged. Philips Respironics will continue with the remediation program.

October 2022 - Insights from a sleep apnoea specialist.
Prof Dr N. de Vries, ENT specialist with a special interest in OSA, seeks to reassure patients affected by the June 2021 field safety notice issued by Philips Respironics related to a component in a certain number of their sleep apnoea devices. His critical review of available major worldwide studies, tracking the health of over 50,000 patients, concludes that there is no statistically significant difference in overall cancer risk associated with the use of Philips Respironics PAP devices containing PE-PUR polyurethane foam when compared with other devices that do not contain PE-PUR foam.

August 2022 - The full results of these tests and epidemiological studies are technical, so we have created a summary of these studies for patients. You can also watch the bellow videos:

Jan Kimpen - Video 1-2

Philips Chief medical Officer Dr. Jan Kimpen talks about the various aspects of the field safety notice

Jan Kimpen - Video 3

Philips Chief Medical Officer Dr. Jan Kimpen speaks about the test and research program

June 28, 2022 Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program.

Frans van Houten and Roy Jakobs

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

Frans van Houten and Roy Jakobs

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

All Patient updates    

Questions and answers

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 Authorization


(Emergency Use Authorisation)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​

DreamStation ST, AVAPS

DreamStation ST, AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T

SystemOne ASV4

SystemOne ASV4

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​

C Series ST, AVAPS

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


60 Series CPAP, ASV

System One 60 series


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)​

Mechanical Ventilators

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

Continuous Ventilator

Trilogy 100

Trilogy 100 Ventilator

Trilogy 200

Trilogy 200 Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

Garbin Plus, Aeris, LifeVent Ventilator

(not marketed in US)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP Hybrid A30

A-Series BiPAP Hybrid A30

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

A-Series BiPAP V30 Auto Ventilator

A-Series BiPAP V30 Auto Ventilator

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

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A40

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

A-Series BiPAP A30

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(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

  • 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.

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