BEUDAMED
    FDA Recall Terminated

    Leksell SurgiPlan

    Recall: Z-1428-2010 · Initiated May 23, 2005

    Recall

    Recall Number
    Z-1428-2010
    Event Number
    55144
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2005
    Posted
    April 22, 2010
    Terminated
    December 14, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Leksell SurgiPlan

    Reason

    Images from a different patient can be imported without a warning for the user.

    Action

    Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elekta.com..

    Distribution

    Nationwide, Canada and Mexico.

    Quantity

    57 units