Philips Respironics, Inc. Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Brand
Philips Respironics, Inc.
Lot Codes / Batch Numbers
Model Number DS2000X11B, UDI-DI Number: 606959052000. All Serial Numbers.
Products Sold
Model Number DS2000X11B, UDI-DI Number: 606959052000. All Serial Numbers.
Philips Respironics, Inc. is recalling Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive v due to Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, whi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Recommended Action
Per FDA guidance
An URGENT Medical Device Correction notification was mailed to consignees on 10/07/2024. The notification provides instructions to users to prevent risks for patients when using in-line nebulizers and a set FiO2. Consignees are to distribute the provided notification to all members of their organization responsible for setting up and supervising patients who use these devices. Additionally, if affected devices were further distributed the notification needs to be provided to them. Philips Respironics is currently investigating the issue and plans to follow-up communications to customers to provide additional guidance and solutions at a later date. Consignees with any questions can contact their local Philips Respironics Customers Service at: For DME and Homecare Customers: 1-800-345-6443, option 4, option 5 For Hospital Customers: 1-800-722-9377, option 2. On 12/27/2024, Philips Respironics sent an updated letter to consignees. It included additional guidance to customers. Dependent upon the scenarios described, customers will be instructed to either contact one of the options provided in the Urgent Medical Device Correction letter for servicing of their device to replace the flow sensor or continue use of the device in accordance with the guidance provided in the Urgent Medical Device Correction letter. Execution of flow sensor replacement will take place through a Field Change Order (FCO).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026