Nidek, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0771-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: February 25, 2019

Date Posted: January 8, 2020

Recall Number: Z-0771-2020

Event ID: 84112

Reason for Recall:

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

Status: Terminated

Product Quantity: 13 devices

Code Information:

Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated