BEUDAMED
    FDA Recall Terminated

    Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.

    Recall: Z-0421-2007 · Initiated November 23, 2006

    Recall

    Recall Number
    Z-0421-2007
    Event Number
    36967
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 23, 2006
    Posted
    February 7, 2007
    Terminated
    May 14, 2008
    Address
    4775 Peachtree Industrial Blvd., Building 300 Suite 300, Norcross, GA, 30092-3023

    Description

    Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.

    Reason

    Unexpected Diaphragm movement when manual field size modifications are not saved.

    Action

    Consignees were notified by letter on/about 11/23/2006

    Distribution

    Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .

    Quantity

    37 units