Recall Z-1508-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Conmed Electrosurgery
Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
| Date | Sep 19, 2006 (initiated Sep 5, 2006) |
| Status | Terminated |
| Reason | Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy. |
| Root cause | Other |
| Action | Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006. |
| Quantity | 44 units (domestic), 40 units (International) |
| Distribution | Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020186 | CONMED SYSTEM 5000 ESU Conmedcorp, Apr 12, 2002 |