Recall Z-2233-2024 ยท NAY System, Surgical, Computer Controlled Instrument
Olympus Corporation of the Americas
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.
| Date | Jun 28, 2024 (initiated Apr 24, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process control |
| Action | Olympus issued Urgent: Medical Device Corrective Action letter on May 24, 2024 via Courier, 2-day delivery. Letter states reason for recall, health risk and action to take: An Olympus representative will reach out to you to schedule an on-site service to perform the earth leakage testing on your facility s ES4K system. You may continue to use your ES4K system until an Olympus representative performs the earth leakage test. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. If you have further distributed this product, ident |
| Quantity | 227 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.