FDA recall Z-0944-2020

Philips Respironics, Inc. · Class I · device

Product

Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B 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

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

Key facts

Status: Terminated
Initiation date: 2019-11-19
Report date: 2020-02-26
Termination date: 2021-03-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2020