BEUDAMED
    FDA Recall Terminated

    Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.

    Recall: Z-1707-2008 · Initiated October 1, 2007

    Recall

    Recall Number
    Z-1707-2008
    Event Number
    49541
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 1, 2007
    Posted
    September 29, 2008
    Terminated
    July 16, 2012
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    Description

    Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.

    Reason

    Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.

    Action

    Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.

    Distribution

    Worldwide distribution, including USA and Japan.

    Quantity

    1203 total