SPECULAR MICROSCOPE CEM-530 — Class II medical device recall Z-2711-2016
Terminated recall by Nidek Inc, reported 2016-09-07, distributed in AL, CA, CT, FL, IN, KS, KY, LA…. Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results featu
| Recall number | Z-2711-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2016-08-08 |
| Classified | 2016-09-01 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-01-09 |
| Distributed | AL, CA, CT, FL, IN, KS, KY, LA, MO, NM, NV, NY, OK, OR, PA, TN, TX, VA |
| Quantity | 29 affected |
| Reason classes | software |
| Serial numbers | 0120016, 0120038, 120004, 120005, 120006, 120007, 120009, 120010, 120011, 120012, 120013, 120014, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 120039, 120040, 120042, 120044, 120045, 120046 and 4 more |
Product
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, 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. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
Reason for recall
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
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-2711-2016. 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.