BEUDAMED
    FDA Recall Terminated

    Digital Radiography System Model DFP8000D

    Recall: Z-0324-06 · Initiated November 10, 2005

    Recall

    Recall Number
    Z-0324-06
    Event Number
    34091
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2005
    Posted
    December 23, 2005
    Terminated
    February 5, 2007
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Digital Radiography System Model DFP8000D

    Reason

    To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.

    Action

    An Advisory Letter was sent to the customers via certified mail. Toshiba issued a Field Modification Instruction (FMI XRA29-90828) to correct that software bug and bring the DFP-8000D into compliance. The FMI is provided to the customers at no charge.

    Distribution

    Nationwide

    Quantity

    72