Class II — 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 II |
| Status | Terminated |
| Reason | 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. |
| 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 co… |
| Quantity | 29 affected devices |
| Distribution | US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN. |
| Initiated | 2016-08-08 |
| Classified | 2016-09-01 |
| Terminated | 2017-01-09 |
| Recall number | Z-2711-2016 |
| 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 II recall — Nidek Inc (Z-2711-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74900/
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