Toshiba American Med Sys Inc X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
All Serial numbers in domestic distribution.
Products Sold
All Serial numbers in domestic distribution.
Toshiba American Med Sys Inc is recalling X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA- due to Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026