# FDA recall Z-0771-2020

> **Nidek, Inc.** · Class III · device recall initiated 2019-02-25.

## 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

- **Recall number:** Z-0771-2020
- **Recalling firm:** Nidek, Inc.
- **Classification:** Class III
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0771-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0771-2020. Source: US FDA. Licensed CC0.

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