Medical Device Recall: 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
Olympus Corporation of the Americas · April 24, 2024
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
Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
States Affected
NATIONWIDE
Quantity Affected
227 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2233-2024
Status: ongoing
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