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U.S. Department of Health and Human Services

Class 2 Device Recall Evita V800 Ventilator

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  Class 2 Device Recall Evita V800 Ventilator see related information
Date Initiated by Firm April 16, 2021
Create Date May 28, 2021
Recall Status1 Terminated 3 on February 06, 2024
Recall Number Z-1691-2021
Recall Event ID 87819
Product Classification Ventilator, continuous, facility use - Product Code CBK
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.
Code Information All lots/serial numbers manufactured from 1/1/2019-3/31201
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael A. Kelhart
215-660-2349
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action 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:
Quantity in Commerce 18 units
Distribution US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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