FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
- Recall number
- Z-0108-2022
- Recalling firm
- Draeger Medical, Inc.
- Product
- Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
- Status
- Open, Classified
- Initiated
- 2021-09-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 6,797 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- Software 2.51 and Lower
- 510(k) numbers
- ["K093633"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28