Z-0870-2022Class II

Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and...

Name: Z-0870-2022 Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and...
Creator: Draeger Medical, Inc.
Published: 2022-02-14
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2022-02-14 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400 on 2022-02-14. FDA classified it as Class II and gives the reason as "Cybersecurity Improvement Action-not equipped against potential cyber security threats". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0870-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-14
Posted: 2022-04-04
Terminated: 2025-01-07
Recalling firm: Draeger, Inc.
Product: Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Cybersecurity Improvement Action-not equipped against potential cyber security threats
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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).
Quantity in commerce: 24,337 (10,728 units US)
Distribution: US Nationwide
Product codes and lots: All Lots/Serial Numbers. UDI: 04048675042266

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0870-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0870-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0871-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-04

Product code CBK

K093633Class IIInfinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa / cleared 2010-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)