Draeger Medical, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
All lots/serial numbers manufactured from 1/1/2019-3/31201
Products Sold
All lots/serial numbers manufactured from 1/1/2019-3/31201
Draeger Medical, Inc. is recalling Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating due to Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of v. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
In April, 2021, Draeger issued an Urgent Medical Device Correction notice to customer via letter notifying them that Draeger became aware of three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800:
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026