Nidek, Inc. recalls NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capt…

Recall date

February 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0771-2020

FDA classification

Class III

Brand / firm

Nidek, Inc.

Sold / distributed

US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.

Why it was recalled

The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.