EVIS EXERA III Video System Center Model Number CV-190 — Class II medical device recall Z-0056-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-10-23, distributed nationwide. Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specificati
| Recall number | Z-0056-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-09-14 |
| Classified | 2024-10-11 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
| UPC / GTIN / UDI-DI | 04953170298622 |
| Serial numbers | 7384422, 7384423, 7384424, 7384441, 7384442, 7384451, 7384455, 7384470, 7384478, 7384479, 7384481, 7384483, 7384484, 7384485, 7384487, 7384489, 7384492, 7384494, 7384495, 7384497, 7384512, 7384516, 7384531, 7384533, 7384543 and 20 more |
| Model numbers | CV-190 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0056-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.