BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0887-2013 · Initiated January 18, 2013

    Recall

    Recall Number
    Z-0887-2013
    Event Number
    64407
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 18, 2013
    Posted
    February 26, 2013
    Terminated
    January 8, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    Aesculap AG sent an Important Recall Notification letter dated January 21, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return for a replacement product or credit. The letter included an inventory sheet to be completed by the customer and returned to the recalling firm. For question call 610-984-9265 or 610-984-9291.

    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