Recall Z-1116-2022 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Olympus Corporation of the Americas
Olympus Uretero-reno videoscope, Model No. URF-V2
| Date | Mar 25, 2022 |
| Status | Open, Classified |
| Reason | The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section. |
| Root cause | Process change control |
| Action | On March 25, 2022, the firm contacted the affected consignee to inform them that certain manufacturing changes by a supplier led to the possibility that a part within the bending section may crack. Olympus repaired the affected URF-V2 unit free of charge. |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of AZ. |
| 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 |