Home / Recalls / Olympus Corporation of the Americas / Z-2029-2024

Z-2029-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
June 12, 2024
Initiation Date
April 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

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 Pattern

US Nationwide distribution in the state of NY.

Code Information

Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

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