[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 an
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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, ambie |
|---|---|
| Brand / manufacturer | Olympus Corporation of the Americas |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2233-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 24 April 2024 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Olympus Corporation of the Americas
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.