FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
- Recall number
- Z-0494-05
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
- Status
- Terminated
- Initiated
- 2004-09-07
- Posted
- not on file
- Terminated
- 2012-02-10
- Reason
- Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.
- Root cause
- Other
- Action
- Firm sent recall letters to customers and will be following up with field corrections which will be made on-site by the firm's own employees.
- Quantity
- 494
- Distribution
- Nationwide.
- Lot, serial or model codes
- All Serial numbers in domestic distribution.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- rad
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- 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