medical Class I Updated 2020-02-26

Philips Respironics, Inc. recalls LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Tr

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: DE

Lot/Code Info: 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,

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