Recall – Ventilator may produce incorrect alarms

Company: Draeger Medical, Inc.
Date of Enforcement Report: 6/9/2021
Class II

PRODUCT

Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 – Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

Recall Number: Z-1690-2021

REASON

Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends warning.

RECALLING FIRM/MANUFACTURER

Draeger Medical, Inc. on 4/16/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

34 units

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

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