Z-0479-2014Class II

Aesculap GNI161 Bipolar Foot Control

Name: Z-0479-2014 Aesculap GNI161 Bipolar Foot Control
Creator: Aesculap, Inc.
Published: 2013-09-10
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-09-10 / Terminated / root cause: design

FDA source

Aesculap, Inc. began a recall of Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar... on 2013-09-10. FDA classified it as Class II and gives the reason as "Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0479-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-10
Posted: 2013-12-11
Terminated: 2014-10-20
Recalling firm: Aesculap Inc
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: all GN161's distributed between 4/28/2009 and 5/22/2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0479-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0479-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-10

Product code GEI

K952524Class IIAesculap Biopolar CoagulatorAesculap, Inc. / cleared 1995-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)