Device product
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Z-2029-2024
Product summary
- Event
- Event 94638
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2029-2024
Official wording
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.
Code information: Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
Distribution pattern: US Nationwide distribution in the state of NY.
Derived failure modes
-
Unknown
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.