BEUDAMED
    FDA Recall Terminated

    LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface

    Recall: Z-1401-06 · Initiated July 7, 2006

    Recall

    Recall Number
    Z-1401-06
    Event Number
    35982
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 7, 2006
    Posted
    August 11, 2006
    Terminated
    March 26, 2008
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface

    Reason

    Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.

    Action

    The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.

    Distribution

    Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland

    Quantity

    23 units