Critical Care Ventilator recall: Software Issue
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term…
Why was Critical Care Ventilator recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots/serial numbers manufactured from 1/1/2019-3/31201
- Product
- Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term…
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 12 units
- Distribution
- US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)