Recall - Ventilator software error leads to loss of all power alarms

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

DISTRIBUTION

Recall – Ventilator software error leads to loss of all power alarms

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