BEUDAMED
    FDA Enforcement Class II Terminated

    MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

    Recall: Z-1598-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1598-2016
    Event ID
    73947
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    April 13, 2016
    Classification Date
    May 3, 2016
    Termination Date
    April 17, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

    Reason

    The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.

    Code Info

    Model # 10432914 and 10432915 Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485

    Distribution

    US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.

    Quantity

    8 systems