FDA recall Z-0056-2025

Olympus Corporation of the Americas · Class II · device

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-09-14
Report date
2024-10-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0056-2025