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. Please reach out to your Philips Respironics Account Manager for any additional questions.
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.
Below is an update on the status of our repair and replacement program for impacted CPAP, BiPAP and mechanical ventilator devices as of October 31, 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. 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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Continue This page covers patients that have purchased their device directly. If you have received your device through the NHS, 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.
06 October 2023
27 September 2023
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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Continue 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.
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.
** 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:
June 28, 2022 - Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program.
August 7, 2023
Click here to learn moreJune 13, 2023
Click here to learn moreFebruary 16, 2023
Click here to learn moreAlso known as DreamStation BiPAP autoSV
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
In-Lab Titration Device
Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)
Also known as BiPAP V30 Auto Ventilator (A-Series)
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
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.
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