FDA Device recall Z-2233-2024
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user inter…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user inter… by Olympus, citing 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 elec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2233-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-24 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
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
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
Identifiers
| code_info | UDI-DI: N/A Serial numbers: BZ-0000004 BZ-0000005 BZ-0000007 BZ-0000008 BZ-0000009 BZ-0000010 BZ-0000015 BZ-0000019 BZ-…UDI-DI: N/A Serial numbers: BZ-0000004 BZ-0000005 BZ-0000007 BZ-0000008 BZ-0000009 BZ-0000010 BZ-0000015 BZ-0000019 BZ-0000022 BZ-0000030 BZ-0000031 BZ-0000034 BZ-0000035 BZ-0000039 BZ-0000040 BZ-0000042 BZ-0000043 BZ-0000047 BZ-0000048 BZ-0000049 BZ-0000050 BZ-0000051 BZ-0000052 BZ-0000056 BZ-0000057 BZ-0000058 BZ-0000059 BZ-0000060 BZ-0000061 BZ-0000062 BZ-0000063 BZ-0000064 BZ-0000065 BZ-0000066 BZ-0000067 BZ-0000068 BZ-0000069 BZ-0000074 BZ-0000075 BZ-0000076 BZ-0000077 BZ-0000079 BZ-0000080 BZ-0000081 BZ-0000082 BZ-0000083 BZ-0000085 BZ-0000086 BZ-0000087 BZ-0000088 BZ-0000089 BZ-0000090 BZ-0000091 BZ-0000092 BZ-0000096 BZ-0000099 BZ-0000103 BZ-0000104 BZ-0000105 BZ-0000106 BZ-0000108 BZ-0000111 BZ-0000112 BZ-0000113 BZ-0000114 BZ-0000116 BZ-0000117 BZ-0000118 BZ-0000140 BZ-0000141 BZ-0000142 BZ-200001 BZ-200005 BZ-200007 BZ-200011 BZ-200012 BZ-200013 BZ-200017 BZ-200018 BZ-200027 BZ-200028 BZ-200029 BZ-200030 BZ-200031 BZ-200032 BZ-200033 BZ-200034 BZ-200037 BZ-200038 BZ-200042 B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2233-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.