Recall Z-0841-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Gyrus Medical, Inc
Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.
| Date | Jul 20, 2004 (initiated Dec 5, 2003) |
| Status | Terminated |
| Reason | The generator may malfunction when used in close proximity to a monopolar generator. |
| Root cause | Other |
| Action | On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device. |
| Quantity | 14 |
| Distribution | Nationwide throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.