RecallDepth

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.

Company
Aesculap Inc
Recall Initiated
September 10, 2013
Posted
December 11, 2013
Terminated
October 20, 2014
Recall Number
Z-0479-2014
Quantity
85
Firm Location
Center Valley, PA

Reason for Recall

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

Distribution

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

Lot / Code Info

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

Root Cause

Device Design

Action Taken

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.

More recalls by Aesculap Inc

View all recalls by this company →