FDA-Device2020-02-26Class I
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo 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.
Philips Respironics, Inc.
Hazard
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.
Sold states
US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
Affected count
5
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2020Don't want to check this manually?
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