Z-2029-2024 Class II Ongoing
FDA device recall Z-2029-2024 was initiated by Olympus Corporation Of The Americas on Apr 18, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2024
- Initiation Date
- Apr 18, 2024
- 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;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2029-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026