Home / Recalls / Medical Devices
Olympus Corporation of the Americas recalls OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Recalled June 12, 2024 · FDA recall Z-2029-2024 · Olympus Corporation of the Americas
Hazard
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. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of NY.
Description
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.
Product
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →