OES 4000 Hysteroscope, Model/Catalog Number: A4674A
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.
US Nationwide distribution in the state of NY.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2024