BEUDAMED
    FDA Recall Terminated

    Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.

    Recall: Z-1460-2008 · Initiated January 3, 2008

    Recall

    Recall Number
    Z-1460-2008
    Event Number
    46919
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    KPQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 3, 2008
    Posted
    July 30, 2008
    Terminated
    September 30, 2009
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.

    Reason

    Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.

    Action

    Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265.

    Distribution

    Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.

    Quantity

    16 UNITS