Recall Z-2029-2024— Olympus Corporation of the Americas

Name: FDA recall Z-2029-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-18

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-04-18. It names one FDA 510(k) clearance: K897003. Product: OES 4000 Hysteroscope, Model/Catalog Number: A4674A. Reason: The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-04-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K897003 — OLYMPUS HYSTERORESECTOSCOPEOlympus Corp.·cleared 1990-03-16

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

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Reason for recall

The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

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