Z-0108-2022Class II

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric...

Name: Z-0108-2022 Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric...
Creator: Draeger Medical, Inc.
Published: 2021-09-10
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2021-09-10 / Open, Classified / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400 on 2021-09-10. FDA classified it as Class II and gives the reason as "Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0108-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-10
Posted: 2021-10-14
Recalling firm: Draeger, Inc.
Product: Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Root cause tag: software
FDA root cause: Software design
Action: Drager issued Urgent Medical Device Recall letter on 9/10/21 via FedEx with tracking (confirmation of delivery). Letter states reason for recall, health risk and action to take: The release of a corrected software is expected to be available in Q4 of 2021. Once the software is available, your local Drger Service representative will contact you to arrange a date for the software update to be performed free of charge. According to our records, at least one of the mentioned affected devices has been shipped to your facility. Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Recall Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. If you have any questions regarding the operation of your Evita V500 or Babylog VN500, please contact Drger 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: 6,797 units
Distribution: US Nationwide
Product codes and lots: Software 2.51 and Lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0108-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0109-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-13

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)