FDA-Device2024-07-10Class II
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.
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
Sold states
Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
Affected count
227 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2024Don't want to check this manually?
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