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 | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. |
| Product | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. |
| Quantity | 5 |
| Distribution | US Distribution in the states of: CA, NE, and NY. |
| Initiated | 2013-05-24 |
| Classified | 2014-11-17 |
| Terminated | 2014-11-17 |
| Recall number | Z-0222-2015 |
| 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-0222-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69531/
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