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).

We are focused on delivering the best care possible, while supporting patients, customers and clinicians throughout the remediation process.

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Globally, we have produced over 98% of new devices and repair kits required for replacement of affected devices*

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Approximately 2,800,000 new devices and repair kits produced to meet the U.S. registration demand*

Approximately 2,300,000 devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**

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Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

Latest 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.

* As of July 31, 2023

** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Repair kits are utilized in the rework process to create a recertified unit. To learn more, click here.

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