BEUDAMED
    FDA Enforcement Class II Terminated

    Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.

    Recall: Z-0887-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0887-2013
    Event ID
    64407
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    January 18, 2013
    Classification Date
    February 26, 2013
    Termination Date
    January 8, 2014
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.

    Reason

    The bipolar energy did not stop after release of the foot pedal.

    Code Info

    Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12

    Distribution

    USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.

    Quantity

    59