FDA-Device2024-10-23Class II
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
Olympus Corporation of the Americas
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
45 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0056-2025Don't want to check this manually?
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