BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1770-2017 · Initiated October 17, 2016

    Recall

    Recall Number
    Z-1770-2017
    Event Number
    76889
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    October 17, 2016
    Terminated
    October 24, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    Siemens mailed an Customer Safety Advisory Notice on October 17, 2016, to all affected customers to inform them of the corrective action they plan to take to correct the issue. The notice also informed users of the possible risks to patients and how the corrective action will be implemented. For further questions, please call (610) 448-6461.

    Distribution

    US Distribution to: DC and MD.

    Quantity

    3 systems distributed in the U.S.