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