Recall Z-1691-2021— Draeger Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Draeger Medical, Inc., initiated 2021-04-16, terminated 2024-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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.
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-16
- Terminated
- 2024-02-06
- Firm location
- Telford, PA, United States
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.