Medical Device recall notification (U.S. only) /
field safety notice (Outside of U.S.)

Philips Respironics

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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.

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

 

Posted: April 25, 2022

This Philips Respironics update is intended to provide healthcare providers, patients, and other stakeholders with updated information on testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for volatile organic compounds (VOCs), particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. The overall guidance for healthcare providers and patients in the most recent version of the recall notification remains unchanged at this time.  

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