BEUDAMED
    FDA Recall Terminated

    Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

    Recall: Z-0479-2014 · Initiated September 10, 2013

    Recall

    Recall Number
    Z-0479-2014
    Event Number
    66533
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 10, 2013
    Posted
    December 11, 2013
    Terminated
    October 20, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

    Reason

    Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.

    Action

    Aesculap sent an Important Recall Notification letter dated September 23, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected product and receive replacement product or credit. An Inventory Sheet is attached and must be completed. For questions call 610-984-9265 or 610-984-9414.

    Distribution

    Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.

    Quantity

    85