Recall Z-1675-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Angiodynamics, INC
AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
| Date | Jul 10, 2013 (initiated Jun 11, 2013) |
| Status | Terminated |
| Reason | The RITA Main Cable product contains the incorrect Instructions for Use. |
| Root cause | Packaging process control |
| Action | Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions. |
| Quantity | 13 units |
| Distribution | Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040989 | RITA SYSTEMS Rita Medical Systems, Apr 28, 2004 |