BEUDAMED
    FDA Recall Terminated

    iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.

    Recall: Z-1436-2010 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-1436-2010
    Event Number
    55064
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 31, 2009
    Posted
    April 26, 2010
    Terminated
    December 14, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.

    Reason

    Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.

    Action

    Elekta sent IMPORTANT NOTICE number A329, dated 31 July, 2009 to all customers. This corresponds with Field Change Order - Documentation 764 00 551 060 "An Important Notice (A329) has been issued for replacement of iViewGT R3.4 Service Pack 2 (SP2) installation CD". Mandatory Field Change Order 764 00 551 059 "Replacement of iViewGT R3.4 installer disk"supersedes FCO 764 00 551 053.

    Distribution

    Nationwide & Puerto Rico

    Quantity

    121 lots