Recall Z-2233-2024— Olympus Corporation of the Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-04-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-24
- Firm location
- Center Valley, PA, United States
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.