Recall Z-0479-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aesculap, Inc.
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.
| Date | Dec 11, 2013 (initiated Sep 10, 2013) |
| Status | Terminated |
| Reason | 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 | 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 | 85 |
| Distribution | Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952524 | AESCULAP BIOPOLAR COAGULATOR Aesculap, Inc., Jun 29, 1995 |