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U.S. Department of Health and Human Services

Class 2 Device Recall Draegar

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 Class 2 Device Recall Draegarsee related information
Date Initiated by FirmFebruary 14, 2022
Create DateApril 04, 2022
Recall Status1 Terminated 3 on January 07, 2025
Recall NumberZ-0870-2022
Recall Event ID 89702
510(K)NumberK093633 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductEvita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Code Information All Lots/Serial Numbers. UDI: 04048675042266
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactSAME
215-721-5400
Manufacturer Reason
for Recall		Cybersecurity Improvement Action-not equipped against potential cyber security threats
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDraeger issued "Urgent Medical Device Correction Notices" on 2/14/22 to the Director, Clinical Engineering and Risk Manager via FedEx with tracking/confirmation of delivery. Letter states reason for recall, health risk and action to take: Continue to follow the recommendations in the instructions for use: o Limit or control physical access to the abovementioned ventilators. o Do not connect any non-approved devices to the USB, LAN and DVI interfaces. o Be attentive to notifications, alarms, and alerts Consider closing/covering all unused USB, LAN and DVI interfaces Should you decide to close/cover unused interfaces, Draeger offers to provide tools upon request to cover or close these data interfaces of the ventilators free of charge. For the intended and authorized use of the interfaces the USB locks and interface covers can be removed with the provided tool. To order this material please contact Dragger Customer Success via phone between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 1 at the prompt, the 2), via fax at 1-215-723-5935, or via email at US-Medical@draeger.com. You will need to know the material number to order, which is dependent on the model of the C500 Cockpit that is installed on your V500/VN500 Ventilator. If you have any questions regarding the operation of your Evita V500 or Babylog VN500, please contact Drager Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1).
Quantity in Commerce24,337 (10,728 units US)
DistributionUS Nationwide
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = CBK
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