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Voluntary Field Safety Notice Information


Philips Respironics Sleep and Respiratory Care devices

Registration for affected CPAP and BiPAP devices in the US and Canada closed on December 31, 2024.

Information for business customers

 

We are committed to partnering with you to support all affected patients.

 

We have continued to make progress on the remediation of CPAP and BiPAP devices and are asking customers and clinicians to help us to remind patients that they may need to take a specific action in the Patient Portal to receive their replacement device.

 

While we've made progress with CPAP and BiPAP devices,  we remain on a separate remediation timeline for ventilation devices.

Ventilation information

Lung icon

Philips Respironics has restarted remediation of Trilogy 100/200 devices in some markets. We will partner with Durable Medical Equipment providers (DMEs) to complete remediation as quickly as possible to address patients on affected Trilogy 100/200 devices. Please visit our ventilation news and updates page for the latest information.

Sleep Therapy information

Sleep icon

Globally, we have remediated 99% of actionable* sleep therapy device registrations to date. 


Continuing to remediate new and existing registrations remains our priority. We will make multiple attempts to ensure we have the information needed to place an order, and will provide responding patients with remediation options. 


*Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting patient or DME action. 

DreamStation 2

Your patients may receive a DreamStation 2 as a replacement for their affected CPAP device.

The Philips Learning connection hosts educational modules that provide overviews of the DreamStation 2 and DreamStation 2 Advanced.

Latest updates

Philips provides update on Respironics recall

October 6, 2023

Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice

September 27, 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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