FDA recall Z-0771-2020

Nidek, Inc. · Class III · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-02-25
Report date
2020-01-08
Termination date
2021-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2020