Z-0949-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- November 19, 2019
- Termination Date
- March 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
Code Information
Model/Material Number: FR2110X14B Serial Numbers: H248213027F13, H249718745CF4, H252330869C7A, H252331053AFD, H255249974881,