BEUDAMED
    FDA Recall Terminated

    Computed Tomography, Models TSX-101A and TSX-021A.

    Recall: Z-1031-04 · Initiated March 17, 2004

    Recall

    Recall Number
    Z-1031-04
    Event Number
    29284
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 17, 2004
    Posted
    July 20, 2004
    Terminated
    November 1, 2011
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Computed Tomography, Models TSX-101A and TSX-021A.

    Reason

    Erroneous patient data is entered. Previoius patient's demographics are recorded.

    Action

    Firm issued Field Modification Instruction which describes the action to be taken by the firm''s own service technicians. Recall letters were sent to each site informing of the issue and provide caution regarding the problem prior to it''s getting fixed.

    Distribution

    Nationwide.

    Quantity

    552