Medical Device Recall Information


Philips Respironics Sleep and Respiratory Care devices

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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 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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