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

Philips Respironics Sleep and Respiratory Care devices

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

Patient safety is our top priority.


We are committed to completing the remediation of all registered devices and have substantially increased the production of replacement devices. 

With devices ready for patients, we are working with customers and clinicians to help get these devices to those who need them. 

It is important that patients feel confident using their devices. Since the field safety notice, we’ve carried out a test and research program to learn more about the polyester-based polyurethane (PE-PUR) sound abatement foam, working with independent laboratories and third party experts and physicians. The latest results of the testing and analysis we have done over the past 18 months can be found here

We know there is still more to be done. As we continue to work through the voluntary field safety notice, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete remediation efforts.

Stop icon

Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

Important updates

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.

November 23, 2022 - Philips provides an update related to Trilogy 100/200 repairs 
Philips Respironics has detected two problems with corrected Trilogy 100/200 ventilators following a limited number of complaints from the US and Japan.

These problems do not affect any of the CPAP or BiPAP sleep apnea devices that have been remediated.

July 25, 2022 - Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk
Philips Respironics engaged external scientific experts to perform an independent systematic literature review of epidemiological studies to evaluate whether use of Continuous or Bilevel Positive Airway Pressure (PAP) devices increases the risk of cancer in obstructive sleep apnea (OSA) patients. 

Based on 13 epidemiological studies identified from the systematic literature review, no association has been established between use of PAP devices, including Philips Respironics PAP devices, and risk of cancer in patients with OSA. Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.

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

May 24, 2022 - An analysis was published online in the European Respiratory Journal that concluded that sustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with other manufacturers’ devices, was not associated with an increased risk of cancer after a median follow-up time of 7.2 years.
The analysis and conclusion were based on data from a large multicenter cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648 Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.

Dec 15, 2021 - A completely independent Canadian study was published in the American Journal of Respiratory and Critical Care Medicine.
This study did not show a higher risk in patients with CPAP compared to patients using a device from another manufacturer.

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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