Class III — Nidek, Inc.
| Recalling firm | NIDEK CO., LTD. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| Quantity | 13 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR. |
| Initiated | 2019-02-25 |
| Classified | 2020-01-02 |
| Terminated | 2021-06-15 |
| Recall number | Z-0771-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Nidek, Inc. (Z-0771-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84112/
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