FDA-Device2023-06-14Class I

Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Philips Respironics, Inc.

Hazard

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

Sold states

US Nationwide. Global Distribution.

Affected count

22,237 devices

Manufactured in

1001 Murry Ridge Ln, Murrysville, PA, United States

Products

Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1652-2023

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