PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: July 10, 2024 Initiated: April 24, 2024 #Z-2233-2024

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

Details

Units Affected
227 units
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Olympus Corporation of the Americas. Units affected: 227 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2233-2024.

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