Recall
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…
Olympus Corporation of the Americas · 24 April 2024
- Status
- Recall open, classified
- Why, in the FDA's words
- “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”
- Recall began
- 24 April 2024
- Company
- Olympus Corporation of the Americas
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.