Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Critical Care Ventilator Recalled by Draeger Medical, Inc. Due to Three separate and unrelated problems attributed to the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Draeger Medical, Inc. directly.
Affected Products
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Quantity: 12 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Draeger Medical, Inc.
Draeger Medical, Inc. has 78 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report