Medical Device Field Safety Notice (outside of U.S.)
Philips Respironics Sleep and Respiratory Care devices
FSN 2021-05-A & FSN 2021-06-A
As of October 2023, Philips Respironics has started repair activities of Trilogy 100/200 devices through Philips-approved repair centers in several countries.
Customers continue to have the choice between the repair of their devices, device buyback in the form of a sales credit, Trilogy Evo upgrades, and a Trilogy Evo loaner program. Our goal is to partner with customers to complete remediation as quickly as possible to address patients on affected Trilogy 100/200 devices.Please reach out to your Philips Respironics Account Manager for any additional questions.
Below is an update on the status of our repair and replacement program for impacted CPAP, BiPAP and mechanical ventilator devices as of February 29, 2024. In addition to the number of replacement devices delivered, we also provide an overview of the number of devices that will be financially compensated and the number of devices that can no longer be traced by home care providers.
1,016,398
Number of repair kits and replacement devices produced for Western Europe
17,458
Number of remediated devices shipped to customers in Ireland
2,258
Financial compensation1 of devices to the home care providers
1,232
Untraceable devices2
1. A number of older System One sleep apnea devices are no longer manufactured and sold by Philips. In many cases, these devices are older than five years. In consultation with the home care providers, Philips has agreed on a solution for these patients. For part of the used devices, home care providers receive alternative or repaired devices. In addition, Philips offers financial compensation for some of these System One devices so that home care providers can purchase another device for the patient.
2. The home care providers have registered a number of devices that are no longer in use or can no longer be traced. The home care providers have made efforts to trace all devices and patients. We assume that devices that are no longer traceable are no longer in use.
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Information for non-HSE Patients
This page covers patients that have purchased their device directly. If you have received your device through the HSE, please click here to go to the page that covers your device. Patient safety is our top priority. We are committed to completing the remediation for all affected patients to make sure you receive safe and effective therapy. We know that each situation is unique depending on your affected device and personal situation. If you have questions about the remediation process or need any additional support once you have received your replacement device, please contact your home care provider or your clinician.
We created a guide outlining each step of the remediation process, so you can understand how we’re handling the recall and what to expect.
Latest updates
Philips provides update on Respironics field safety notice
06 October 2023
Philips response to recent media articles related to Philips Respironics’ voluntary field safety notice
27 September 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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Understand the steps we take to ensure the safety of your replacement CPAP or BiPAP device
While we work to provide replacement devices as quickly as possible, we want to share the steps we are taking to ensure your First Generation DreamStation replacement device is safe to use so you can be confident in your new device.
Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.
Support at every step of the way
Learn about the Field Safety Notice and register your affected device
Learn more about your replacement device
Return your affected device
News and updates
December 21, 2022 - Update on completed testing for first-generation DreamStation devices Based on the extensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices.
Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients
Jan Bennik, Head of Test and Research Program, explains the details behind the testing results
** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Philips Respironics’ guidance for healthcare providers and patients remains unchanged. Philips Respironics will continue with the remediation program.
October 2022 - Insights from a sleep apnoea specialist.
Prof Dr N. de Vries, ENT specialist with a special interest in OSA, seeks to reassure patients affected by the June 2021 field safety notice issued by Philips Respironics related to a component in a certain number of their sleep apnoea devices. His critical review of available major worldwide studies, tracking the health of over 50,000 patients, concludes that there is no statistically significant difference in overall cancer risk associated with the use of Philips Respironics PAP devices containing PE-PUR polyurethane foam when compared with other devices that do not contain PE-PUR foam.
August 2022 - The full results of these tests and epidemiological studies are technical, so we have created a summary of these studies for patients. You can also watch the bellow videos:
Philips Chief medical Officer Dr. Jan Kimpen talks about the various aspects of the field safety notice
Philips Chief Medical Officer Dr. Jan Kimpen speaks about the test and research program
June 28, 2022 - Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program.
Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice
Technical Project Manager Jan Bennik speaks about the test and research program
All Patient updates
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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
Click here to learn more -
![A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care]()
A conversation with David Ferguson, Business Leader, Sleep and Respiratory Care
June 13, 2023
Click here to learn more -
![Dr. Jan Kimpen, Senior Medical Advisor, answers key questions from patients]()
Dr. Jan Kimpen, Senior Medical Advisor, answers key questions from patients
February 16, 2023
Click here to learn more -
![Replacement device troubleshooting]()
Questions and answers
DreamStation ASV
Also known as DreamStation BiPAP autoSV
DreamStation ST, AVAPS
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
SystemOne ASV4
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
C Series S/T, AVAPS
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
OmniLab Advanced Plus
In-Lab Titration Device
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30
Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP V30 Auto Ventilator
Also known as BiPAP V30 Auto Ventilator (A-Series)
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP A30
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
What products are not affected and why?
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
