Recall Z-0859-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien LP
Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
| Date | May 10, 2006 (initiated Apr 21, 2006) |
| Status | Terminated |
| Reason | Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode. |
| Root cause | Other |
| Action | Consignees were notified by telephone followed by a fax on 04/21/2006. |
| Quantity | 137 units |
| Distribution | Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984552 | COOL-TIP RF SYSTEM Radionics, Inc., Mar 5, 1999 |