Lower riskMedical device recall · FDA · Published April 24, 2024
Olympus EasySuite 4K System Recall: Earth Leakage Testing Records Missing
Olympus recalls EasySuite 4K Integrated Operating Room Systems with incomplete earth leakage testing records. Affected units may pose electrical safety risks. Consumers should check serial numbers listed in the recall notice.
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
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus EasySuite 4K System Recall: Earth Leakage Testing Records Missing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55309-olympus-easysuite-4k-system-recall-earth-leakage-testing-records-missing. Based on FDA recall #Z-2233-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2233-2024%22&limit=1).
The FDA announced on April 24, 2024, that Olympus Corporation of the Americas is recalling EasySuite 4K Integrated Operating Room Systems. The hazard involves incomplete earth leakage testing records for a subset of units. Owners should contact the company for remedy details.
How to tell if you have it
Brand: Olympus
Product: EasySuite 4K Integrated Operating Room System
Model/Catalog Number: EasySuite 4K
Serial numbers: BZ-0000004 through BZ-0000161, BZ-200001 through BZ-200071, BZ-300001 through BZ-300025, BZ-600004 through BZ-600147, BZ-700001, FLX-200001 through FLX-200215, BZ-0000036 through BZ-0000129, BZ-100001 through BZ-100030, FLX-300003, FLX-300005, BZ-400001, BZ-400002, FLX-300002
Units affected: 227
The hazard
A subset of the EasySuite 4K 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.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable recall (2026-08-27), the Olympus M3 Gold Autoclavable Lateral Telescope recall (2026-08-24), and the BiCOAG Hemostasis Probe Connector Recall (2026-08-19). Other recent recalls of similar products include the Olympus OER-Pro Recall (2025-10-31), the Spacelabs Ultraview SL Command Module Software Recall (2026-03-26), and the Olympus OER-Elite Recall (2025-10-31).
How to tell if you have this one
Check if your EasySuite 4K system has a serial number from the list provided in the recall notice. The affected units include specific serial numbers starting with BZ- or FLX-.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Review the list of affected serial numbers provided in the recall notice to determine if your system is included.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2233-2024 (April 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2233-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.