Recall Z-0887-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aesculap, Inc.
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
| Date | Feb 26, 2013 (initiated Jan 18, 2013) |
| Status | Terminated |
| Reason | The bipolar energy did not stop after release of the foot pedal. |
| Root cause | Nonconforming Material/Component |
| Action | Aesculap AG sent an Important Recall Notification letter dated January 21, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return for a replacement product or credit. The letter included an inventory sheet to be completed by the customer and returned to the recalling firm. For question call 610-984-9265 or 610-984-9291. |
| Quantity | 59 |
| Distribution | USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.