FDA Device

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

Hazard

Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.

What You Should Do

Remedy

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.

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Products

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
Brand
Toshiba American Med Sys Inc
UPC
All Serial numbers in domestic distribution.

Units Affected

494

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