Class II
Medical Device Recall: OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Olympus Corporation of the Americas · April 18, 2024
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.
Distribution
US Nationwide distribution in the state of NY.
States Affected
NATIONWIDE
Quantity Affected
1 unit
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2029-2024
Status: ongoing
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