Recall Z-0888-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Rita Medical Systems, Inc.
XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
| Date | May 31, 2006 (initiated May 2, 2006) |
| Status | Terminated |
| Reason | Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker |
| Root cause | Other |
| Action | Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006. |
| Quantity | 19 units |
| Distribution | AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010060 | RITA STARBURST XLI ELECTROSURGICAL DEVICE Rita Medical Systems, Jan 23, 2001 |