Recall Z-1076-04 ยท JOS Electrode, Electrosurgical
Rita Medical Systems
Dispersive Electrodes packaged in an 8x10 plastic container.
| Date | Jul 20, 2004 (initiated Jun 16, 2004) |
| Status | Terminated |
| Reason | Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed. |
| Root cause | Other |
| Action | Each hospital that has been shipped the devices will receive a recall letter during the week of june 21, 2004 with materials for return shipping. Field representatives will receive notice of the recall, and will return any unused devices and document consumed devices. |
| Quantity | 468 sets (each set consists of two pads) |
| Distribution | Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.