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Nidek, Inc. recalls NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image captu
Recalled January 8, 2020 · FDA recall Z-0771-2020 · Nidek
Hazard
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) · FDA Class III
Units
13 devices
Sold at
US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
Description
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
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.
Manufacturer(s)
Nidek, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →