Operating Room System Recalled for Incomplete Electrical Safety Testing Records
Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall involving incomplete testing documentation rather than a confirmed product defect or reported harm. The issue is the absence of complete earth leakage testing records needed to verify electrical safety compliance, not a demonstrated safety failure.
Plain-English summary
Olympus Corporation of the Americas is recalling 227 EasySuite 4K Integrated Operating Room Systems. These systems include a touch panel user interface for routing procedural video to operating room displays and for controlling room video cameras, surgical cameras, ambient lighting, and surgical lights.
The recall affects units with specific serial numbers distributed worldwide, including the US nationwide and internationally in Germany and Hong Kong. A subset of these systems do not have complete records for earth leakage testing, which is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits.
Affected facilities should contact Olympus Corporation of the Americas to determine if their EasySuite 4K system is affected and obtain guidance on testing records verification or any necessary corrective actions.
The recalled product
- 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, sur
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- electrical-safety
- incomplete-testing-records
Distribution
Distributed nationwide across the United States.
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