PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: February 26, 2020 Initiated: November 19, 2019 #Z-0949-2020

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.

Details

Recalling Firm
Philips Respironics, Inc.
Units Affected
5
Distribution
US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
Location
Murrysville, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Philips Respironics, Inc.. Units affected: 5.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2020. Severity: Critical. Recall number: Z-0949-2020.