BEUDAMED
    FDA Recall Terminated

    NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.

    Recall: Z-0838-2009 · Initiated July 28, 2008

    Recall

    Recall Number
    Z-0838-2009
    Event Number
    50136
    Firm
    Neurotherm, Inc.
    FEI Number
    3002953813
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 28, 2008
    Posted
    January 13, 2009
    Terminated
    September 24, 2009
    Address
    2 De Bush Ave, Unit A2, Middleton, MA, 01949-1679

    Description

    NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.

    Reason

    Distal tip may detach from the probe

    Action

    NeuroTherrn sales representatives were notified telephonically or through e-mail. End users were notified through visits by NeuroTherm sales representatives on 7/28/08 and 8/15/08. For questions, please contact NeuroTherm, Inc. at 1-978-777-3916.

    Distribution

    CO, FL, IL, OH, TN, TX , VA, and WY Foreign: Australia, China, and UK,

    Quantity

    71 units