Recall Z-0056-2025 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
| Date | Oct 11, 2024 (initiated Sep 14, 2023) |
| Status | Open, Classified |
| Reason | Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION notification letter dated 9/14/23 was sent to customers. Action steps to be taken by the end user: Olympus has determined based upon our distribution records that your facility is in possession of one or more affected CV-190 with a serial number shown in Attachment 1. Olympus requires that you take the following actions: 1. Inspect your inventory for the referenced products and identify any devices with the model number and serial number specified in Attachment 1. Cease use of products and quarantine any affected products. Please check all are |
| Quantity | 45 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131780 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corp., Aug 29, 2013 |