Recall Z-0144-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.
| Date | Nov 19, 2003 (initiated Sep 15, 2003) |
| Status | Terminated |
| Reason | The Hyfrecator 2000 units were released without documented adherence to their voltage output specification. |
| Root cause | Other |
| Action | All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit. |
| Quantity | 10 units |
| Distribution | Units were distributed to CA, CT,IL and ME. International distribution to Phillipines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970493 | HYFRECATOR 2000 Aspen Labs, Apr 30, 1997 |