Z-1691-2021 Class II Terminated
FDA device recall Z-1691-2021 was initiated by Draeger Medical, Inc. on April 16, 2021 and is designated Class II. 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 l… The recall status is terminated (terminated February 6, 2024). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 16, 2021
- Termination Date
- February 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
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
Distribution Pattern
US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Code Information
All lots/serial numbers manufactured from 1/1/2019-3/31201