PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 23, 2024 Initiated: September 14, 2023 #Z-0056-2025

Product Description

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.

Details

Units Affected
45 units
Distribution
US Nationwide distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Olympus Corporation of the Americas. Units affected: 45 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0056-2025.