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.
FDA Recall Z-0479-2014 · Posted 2013-12-11
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Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2013-09-10
Date Terminated2014-10-20
Product Quantity85
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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