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.
- Company
- Draeger Medical, Inc.
- Recall Initiated
- April 16, 2021
- Terminated
- February 6, 2024
- Recall Number
- Z-1692-2021
- Quantity
- 2 units
- Firm Location
- Telford, PA
Reason for Recall
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
Distribution
US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Lot / Code Info
All lots/serial numbers manufactured from 1/1/2019-3/31201
Root Cause
Software design
Action Taken
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:
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