Reported Jul 10, 2024 · Ongoing
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- EasySuite 4K Integrated Operating
- Room System Model/Catalog NumberEasySuite 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
- Lot codes and dates
- UDI-DIN/A
- Serial numbers
227 of 227 codes
BZ-0000004BZ-0000005BZ-0000007BZ-0000008BZ-0000009BZ-0000010BZ-0000015BZ-0000019BZ-0000022BZ-0000030BZ-0000031BZ-0000034BZ-0000035BZ-0000039BZ-0000040BZ-0000042BZ-0000043BZ-0000047BZ-0000048BZ-0000049BZ-0000050BZ-0000051BZ-0000052BZ-0000056BZ-0000057BZ-0000058BZ-0000059BZ-0000060BZ-0000061BZ-0000062BZ-0000063BZ-0000064BZ-0000065BZ-0000066BZ-0000067BZ-0000068BZ-0000069BZ-0000074BZ-0000075BZ-0000076BZ-0000077BZ-0000079BZ-0000080BZ-0000081BZ-0000082BZ-0000083BZ-0000085BZ-0000086BZ-0000087BZ-0000088BZ-0000089BZ-0000090BZ-0000091BZ-0000092BZ-0000096BZ-0000099BZ-0000103BZ-0000104BZ-0000105BZ-0000106
- Amount recalled
- 227 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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