Company: Philips Respironics, Inc.
Date of Enforcement Report: 2/26/2020
Class I
PRODUCT
Trilogy EVO Ventilator, International, Model Number IN2110X15B 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.
- Recall Number: Z-0942-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Respironics, Inc. on 11/19/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
21
DISTRIBUTION
US