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.

Code information: all GN161's distributed between 4/28/2009 and 5/22/2013.

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