Recall Z-0056-2025— Olympus Corporation of the Americas

Name: FDA recall Z-0056-2025
Creator: U.S. Food and Drug Administration
Published: 2023-09-14

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-09-14. It names one FDA 510(k) clearance: K131780. 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: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-09-14
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K131780 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corp.·cleared 2013-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.