BEUDAMED
    FDA Recall Terminated

    Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.

    Recall: Z-1652-2009 · Initiated April 14, 2009

    Recall

    Recall Number
    Z-1652-2009
    Event Number
    52430
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 14, 2009
    Posted
    July 7, 2009
    Terminated
    September 21, 2012
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087

    Description

    Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.

    Reason

    Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.

    Action

    HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.

    Distribution

    Nationwide distribution, including Puerto Rico (PR).

    Quantity

    4 units