Recall Z-2518-2018 ยท OCS Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Olympus Corporation of the Americas
Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
| Date | Jan 17, 2018 |
| Status | Terminated |
| Reason | Potential breakage of the endoscope s insertion tube bending section during surgical procedures |
| Root cause | Device Design |
| Action | On 1/16/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures. Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-V2/V2R models; 2.Olympus will contact your facility to make arrangements for return of your URF-V2/V2R u videoscope(s) for the device exchange. You will be provided instructions on return |
| Quantity | 2548 |
| Distribution | US Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172246 | OLYMPUS URF-V2/V2R Olympus Medical Systems Corp., Mar 30, 2018 |