FDA-Device2021-06-09Class II
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Draeger Medical, Inc.
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
Sold states
US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Affected count
18 units
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2021Don't want to check this manually?
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