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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap GNI161 Bipolar Foot Control

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 Class 2 Recall
Aesculap GNI161 Bipolar Foot Control
see related information
Date Posted December 11, 2013
Recall Status1 Open
Recall Number Z-0479-2014
Recall Event ID 66533
Premarket Notification
510(K) Number
K952524 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product 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.
Code Information all GN161's distributed between 4/28/2009 and 5/22/2013.
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley, Pennsylvania 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 85
Distribution Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = AESCULAP, INC.
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