Draeger Medical, Inc. Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Recommended Action

Per FDA guidance

Draeger 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).