Z-0494-05

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

Name: Z-0494-05 X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
Creator: Toshiba American Med Sys Inc
Published: 2004-09-07
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-09-07 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D on 2004-09-07. The reason FDA records is "Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0494-05
Status: Terminated
Initiated: 2004-09-07
Posted: 2015-06-25
Terminated: 2012-02-10
Recalling firm: Canon Medical Systems USA, Inc.
Product: X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
Product code: rad
Reason for recall: Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.
Root cause tag: software
FDA 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 in commerce: 494
Distribution: Nationwide.
Product codes and lots: All Serial numbers in domestic distribution.

Product code rad

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)