BEUDAMED
    FDA Recall Terminated

    Mevatron M2/Primus Mid-Energy PRIMUS HI

    Recall: Z-1489-2017 · Initiated February 14, 2017

    Recall

    Recall Number
    Z-1489-2017
    Event Number
    76712
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 14, 2017
    Terminated
    December 18, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Mevatron M2/Primus Mid-Energy PRIMUS HI

    Reason

    Software update

    Action

    Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.

    Distribution

    Distributed throughout the United States

    Quantity

    80 systems