Voluntary Recall 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
Approximately 2,840,000 new devices and repair kits produced to meet the U.S. registration demand*
Approximately 2,490,000 devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**
Are you or your patient waiting for a replacement device? We may be trying to reach you for more information or to take additional action.
Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice
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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![Tools and resources to support your patients]()
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![Latest results and conclusions on the comprehensive test results for home sleep therapy devices]()
Latest results and conclusions on the comprehensive test results for home sleep therapy devices
August 7, 2023
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![Resources for Clinicians and Physicians]()
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![I don’t have my prescription yet. What are my options?]()
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![Waiting for your replacement device? Here are the actions you may need to take to continue your remediation pathway.]()
Waiting for your replacement device? Here are the actions you may need to take to continue your remediation pathway.
June 29, 2023
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![A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care]()
A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care
June 12, 2023
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![Ventilation news and updates]()
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![Important information about patient prioritization]()
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![Dr. Jan Kimpen, Senior Medical Advisor, answers key questions from patients]()
Dr. Jan Kimpen, Senior Medical Advisor, answers key questions from patients
February 13, 2023
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![Replacement device troubleshooting]()
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![The Patient Portal: Why you should use it and what to expect]()
The Patient Portal: Why you should use it and what to expect
December 14, 2022
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![Replacement device safety information]()
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![How to return your affected device]()
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![Quick tips to guide you through the remediation process]()
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![External studies summary of the risk of cancer for Philips Respironics users was not higher compared to other brands]()
External studies summary of the risk of cancer for Philips Respironics users was not higher compared to other brands
August 11, 2022
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![Testing update for patients]()
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![Who’s who in the remediation]()
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![Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program]()
Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program
June 28, 2022
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![Replacement Trilogy Circuit Inspection and Cleaning Instructions]()
Replacement Trilogy Circuit Inspection and Cleaning Instructions
June 1, 2022
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![Understanding the recall process]()
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![Philips provides update on the test and research program]()
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![Important update to Philips US recall notification]()
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![Cleaning and inspection instructions for existing accessories]()
Cleaning and inspection instructions for existing accessories
September 3, 2021
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![Philips starts repair and/or replacement program of first-generation DreamStation devices]()
Philips starts repair and/or replacement program of first-generation DreamStation devices
September 1, 2021
Click here to learn more -
![A message from David Ferguson]()
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![Updates to Questions and Answers]()
* As of August 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.
