BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

    Recall: Z-2401-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2401-2019
    Event ID
    83556
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    September 4, 2019
    Initiation Date
    July 31, 2019
    Classification Date
    August 27, 2019
    Termination Date
    December 2, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

    Reason

    The injector holder could potentially fall off together with the injector and the storage box.

    Code Info

    Serial Number 108183 108177 108176

    Distribution

    US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD

    Quantity

    3 units