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Olympus Corporation of the Americas recalls EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a to
Recalled July 10, 2024 · FDA recall Z-2233-2024 · Olympus Corporation of the Americas
Hazard
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 · FDA Class II
Units
227 units
Sold at
Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
Description
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
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.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →