Olympus Corporation of the Americas: Device Recall

Recall #Z-2029-2024 · 04/18/2024

Class II: Risk

Recall Details

Recall Number
Z-2029-2024
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
04/18/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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.

Product Description

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Distribution Pattern

US Nationwide distribution in the state of NY.

Other Recalls by Olympus Corporation of the Americas

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.