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

Philips Respironics Sleep and Respiratory Care devices


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

Important updates

Philips provides update on Respironics field safety notice

06 October 2023

Philips response to recent media articles related to Philips Respironics’ voluntary field safety notice

27 September 2023

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.

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

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

May 2023 - update on completed testing for home sleep therapy devices shows no appreciable harm to patients

The tests, conducted together with five independent, certified testing laboratories and assessed by third-party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.

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.

News and updates    

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