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