FDA-Device2024-06-12Class II
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
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.
Sold states
US Nationwide distribution in the state of NY.
Affected count
1 unit
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2024Don't want to check this manually?
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