Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

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News and Updates > Testing results for affected devices

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.

Documents

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

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

 

Posted: 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.

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

 

Posted: July 8, 2022

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

 

Posted: June 28, 2022

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

 

Posted: April 25, 2022

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