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

Philips Respironics

FSN 2021-05-A & FSN 2021-06-A

If you haven't yet registered your device

0800 249 4578 (UK) or (0044) 20 8089 3822 (outside of UK)

News and Updates > Resources for Clinicians and Doctors

Resources for Clinicians and Doctors

September 2023

These communications were created to help update doctors on recent developments as well as provide a status update on remediation efforts.


Please check back for new content as this page will be updated regularly.


For more information about the field safety notice, please

Clinical bulletins

New and reassuring results

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. 

Updated: July 25, 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

Updated: June 28, 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.

Updated: May 24, 2022

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.

Updated: December 15, 2021

Additional clinical information

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

If you haven't yet registered your device

0800 249 4578 (UK) or (0044) 20 8089 3822 (outside of UK)

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