BEUDAMED
    FDA Enforcement Class II Terminated

    Mevatron M2/Primus Mid-Energy PRIMUS HI

    Recall: Z-1489-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1489-2017
    Event ID
    76712
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    February 14, 2017
    Classification Date
    March 20, 2017
    Termination Date
    December 18, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Mevatron M2/Primus Mid-Energy PRIMUS HI

    Reason

    Software update

    Code Info

    Device Model# 1940035, 4504200

    Distribution

    Distributed throughout the United States

    Quantity

    80 systems