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Draeger Medical, Inc. recalls Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who requ
Recalled June 9, 2021 · FDA recall Z-1692-2021 · Draeger Medical
Hazard
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 weaning · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Description
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 weaning
Product
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Manufacturer(s)
Draeger Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →