medical Class III Updated 2020-01-08

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →