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).
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)**
** 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.
News and updates
May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients
The tests, conducted together with five independent, certified testing laboratories and assessed by third- party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.
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![Resources for Clinicians and Physicians]()
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![Ventilation news and updates]()
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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.
April 12, 2023
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![Important information about patient prioritization]()
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![Tools and resources to support your patients]()
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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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![I don’t have my prescription yet. What are my options?]()
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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
Click here to learn more -
![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
Click here to learn more -
![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]()
