Philips Respironics, Inc. recalls Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult pati…

Recall date

November 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0952-2020

FDA classification

Class I

Brand / firm

Philips Respironics, Inc.

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B 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.