LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B 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.

Reason: 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.

Code information: Model/Material Number: SP2100X26B Serial Numbers: H25538574D9D9, H256917933B78, H2569193868C0, H2569196907F1, H25691987749F, H256920522A99, H2569224829A3, H256924542CCE, H256925062BB8, H25692591881F, H25692661E4B3, H25692712C1FC, H25692910F2F5, H25692952B687, H256930400CE8, H25693118A4C4, H2569421090C9, H256943094E0C, H25755370F165, H25755371E0EC, H25755372D277, H25769443EF6B, H2576945959E9, H2576949608BE, H25769512DA86, H25769515AE39, H257695178D2B, H257699654692, H25772204E13C,

Distribution pattern: US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ