BEUDAMED
    FDA Recall 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 · Initiated April 13, 2016

    Recall

    Recall Number
    Z-1598-2016
    Event Number
    73947
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    April 13, 2016
    Posted
    May 3, 2016
    Terminated
    April 17, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    Siemens mailed to customers on April 13, 2016, a Customer Safety Advisory Notice, MR013/16/S, to inform them of the actions to take to prevent a possible hazard to persons and equipment. Customers were informed that they will be contacted by one of Siemens' service organization who will schedule an appointment to perform a correction, which is to exchange the top cover.

    Distribution

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

    Quantity

    8 systems