Recall Z-0754-2017 ยท FAS Electrode, Electrosurgical, Active, Urological
Olympus Corporation of the Americas
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
| Date | Nov 3, 2016 |
| Status | Terminated |
| Reason | Software malfunction that results in incorrect generation or display of error codes. |
| Root cause | Under Investigation by firm |
| Action | Olympus mailed on 11/03/2016 an Urgent Communication Letter to customers affected by the recall. The letter requested that consignees inspect their inventory for the affected lots and call Customer Service to obtain a Returned Material Authorization (RMA) to return the product. |
| Quantity | 494 units |
| Distribution | Distributed Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES Olympus Winter & Ibe GmbH, Jun 20, 2012 |