Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

News and Updates > Testing results for affected devices

For Clinicians

Testing results for affected devices

In June 2021, after discovering potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification.

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

Resources for Clinicians and Physicians

PE-PUR testing results and conclusions

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

July 24, 2023

View/download report (683.0KB)

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

May 16, 2023

View/download report (651.0KB)

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

December 21, 2022

View/download report (617.0KB)

Testing summary for use with your patients (274.0KB)

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

June 28, 2022

View/download report (505.0KB)

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)

Third party epidemiological studies - Frequently Asked Questions related to the 2022 Swedish study by Palm et al.

July 8, 2022

View/download report (201.0KB)

You are now exiting the Philips United States (US) site and entering the Philips global site. This content is intended for a global audience. It may not apply to the US and should not be interpreted as meeting US standards, executive orders or regulations.

Continue

Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

For Clinicians

Testing results for affected devices

Resources

PE-PUR testing results and conclusions

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

Philips Respironics Update on PE-PUR Testing Results and Conclusions Available to Date

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

Other testing documents

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

Third party epidemiological studies - Frequently Asked Questions related to the 2022 Swedish study by Palm et al.