# FDA recall Z-2233-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-04-24.

## 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

- **Recall number:** Z-2233-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2233-2024. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2233-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*