Recall Z-0087-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Rita Medical Systems
RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
| Date | Nov 1, 2003 (initiated Oct 6, 2003) |
| Status | Terminated |
| Reason | The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading. |
| Root cause | Other |
| Action | On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall. |
| Quantity | 137 + 225 units (lot Y082003) |
| Distribution | Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it inclu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031926 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) Rita Medical Systems, Inc., Jul 17, 2003 |