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Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Recalled June 14, 2023 · FDA recall Z-1652-2023 · Philips Respironics

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. · FDA Class I
Units
22,237 devices
Sold at
US Nationwide. Global Distribution.

Description

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.

Product
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Manufacturer(s)
Philips Respironics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model Number DS2000X11B | RecallWatchUSA