Nidek, Inc. recalls NIDEK Specular Microscope, Model CEM-530 - Product Usage: Th
Recalled Product
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
Hazard / Issue
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Issued by
FDA
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