Testing results for affected devices

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Testing results for affected devices

In June 2021, after discovering a potential health risk related to a part in specific CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (FSN 2021-05-A & FSN 2021-06-A).

We continue to work with independent partners to conduct extensive testing and analysis of results on affected devices, including biocompatibility evaluations.

Please check this page for updates frequently as we will add new testing results documents as they become available.

Resources

Recall homepage

PE-PUR testing results and conclusions

We will continue to add up-to-date information within this section as new testing results become available.

Actualización de Philips Respironics sobre los resultados de las pruebas de PE-PUR y las conclusiones disponibles a fecha

16 de mayo de 2023

Ver/descargar el informe completo (en inglés) (651.0KB)

Actualización del 21 de diciembre de 2022 sobre las pruebas completadas en dispositivos DreamStation de primera generación

21 de diciembre de 2022

Lea el comunicado de prensa

Lea el informe completo (en inglés)

(617.0KB)

Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

June 28, 2022

View/download report (505.0KB)

Read the press release

Philips Respironics Summary of PE-PUR Testing Results and Conclusions Available to Date

April 25, 2022

View/download report (347.0KB)

Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk

July 25, 2022

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.

View/download report (187.0KB)

For clinicians