BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0494-05 · Initiated September 7, 2004

    Recall

    Recall Number
    Z-0494-05
    Event Number
    31217
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    rad
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 7, 2004
    Terminated
    February 10, 2012
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

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

    Reason

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

    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.

    Distribution

    Nationwide.

    Quantity

    494