FDA Medical devices recall ·
EVIS EXERA III Video System Center Model Number CV-190… recall
- Recall number
- Z-0056-2025
- Date
- (initiated September 14, 2023)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 04953170298622; Serial Numbers: 7384484 7384422 7384487 7384478 7384479 7384442 7384441 7384485 7384451 7384455 7384481 7384470 7384424 7384423 7384489 7384531 7384516 7384492 7384512 7384543 7384483 7384624 7384623 7384497 7384495 7384494 7384533 7384622 7384660 7384654 7384656 7384647 7384658 7384675 7384655 7384704 7384709 7384687 7384706 7384661 7384662 7384703 7384670 7384679 7384678
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0056-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.