Olympus Corporation of the Americas: Device Recall

Recall #Z-2233-2024 · 04/24/2024

Class II: Risk

Recall Details

Recall Number
Z-2233-2024
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
04/24/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
227 units

Reason for Recall

A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits

Product Description

EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.

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.