BEUDAMED
    FDA Enforcement Class II Terminated

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    Recall: Z-1678-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1678-2020
    Event ID
    85161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2020
    Initiation Date
    February 18, 2020
    Classification Date
    April 7, 2020
    Termination Date
    February 9, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

    Reason

    Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

    Code Info

    Serial Numbers 2507, 2516, 2596, 2689, 2818, 2962, 3013, 3103, 3089, 3136, 2855, 3296, 3397, 3591, 3629, 3639, 3644, 3702, 3873, 3939, 4018, 3986, 70-4146, 70-4347, 70-4363, 5092, 5114, 5523, 70-4287, 2045, 2067, 2125

    Distribution

    Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

    Quantity

    1012