Evita V500 Ventilator with Software 2.51.01 and Lower -… recallZ-0870-2022 · Draeger Medical, Inc. · initiated Feb 14, 2022

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
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Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Cybersecurity Improvement Action-not equipped against potential cyber security threats

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected]. 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).

Recall details

Recall number: Z-0870-2022
Status: Terminated
Initiated by the company: Feb 14, 2022
Recalling firm: Draeger Medical, Inc.
Quantity: 24,337 (10,728 units US)
Product code: CBK
FDA submissions: K093633
Distribution: US Nationwide

Product description

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

Code information (models, lots, serial numbers)

All Lots/Serial Numbers. UDI: 04048675042266

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

IACS Workstation Critical Care 8416400
Drägerwerk AG & Co. KGaA · Ventilator, Continuous, Facility Use
1 recall5 deaths213 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 89702).

Z-0871-2022 · Terminated
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 k…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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