BEUDAMED
    FDA Recall Terminated

    Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.

    Recall: Z-0841-04 · Initiated December 5, 2003

    Recall

    Recall Number
    Z-0841-04
    Event Number
    27883
    Firm
    Gyrus Medical, Inc
    FEI Number
    3011050570
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2003
    Posted
    July 20, 2004
    Terminated
    December 28, 2006
    Address
    6655 Wedgewood Road, Maple Grove, MN, 55311

    Description

    Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.

    Reason

    The generator may malfunction when used in close proximity to a monopolar generator.

    Action

    On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device.

    Distribution

    Nationwide throughout the United States.

    Quantity

    14