FDA recall Z-2233-2024

Olympus Corporation of the Americas · Class II · device

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 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

Distribution

Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.

Key facts

Status
Ongoing
Initiation date
2024-04-24
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2024