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Voluntary Field Safety Notice Information


Philips Respironics Sleep and Respiratory Care devices


In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).

News and updates    

Philips provides update on Respironics recall

October 6, 2023

Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice

September 27, 2023

July 2023 latest results and conclusions for sleep therapy devices related to the impact of ozone cleaning shows no appreciable harm to health in patients

 

Philips Respironics completed the analyses for System One and DreamStation Go sleep therapy devices indicating that the volatile organic compounds (VOCs) and the particulate matter (PM) emissions related to foam degradation are within the appliable safety limits. Additional visual assessments have been performed and confirm the low prevalence of significant foam degradation.

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