FDA Device recall Z-0479-2014
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical p…
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical p… by Aesculap, citing complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0479-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-10 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | US |
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.
Reason
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Identifiers
| code_info | all GN161's distributed between 4/28/2009 and 5/22/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0479-2014%22
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