BEUDAMED
    FDA Enforcement Class II Terminated

    Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

    Recall: Z-1770-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1770-2017
    Event ID
    76889
    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 19, 2017
    Initiation Date
    October 17, 2016
    Classification Date
    April 10, 2017
    Termination Date
    October 24, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

    Reason

    Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.

    Code Info

    Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017

    Distribution

    US Distribution to: DC and MD.

    Quantity

    3 systems distributed in the U.S.