NIDEK Specular Microscope — Class III medical device recall Z-0771-2020
Terminated recall by Nidek, Inc., reported 2020-01-08, distributed nationwide. The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 606
| Recall number | Z-0771-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek, Inc., Fremont, CA, United States |
| Recall initiated | 2019-02-25 |
| Classified | 2020-01-02 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2021-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 13 devices |
| Serial numbers | 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, 170001 |
| Model numbers | CEM-530 |
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0771-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.