MC-500 Multicolor Laser Photocoagulator using software version 2 — Class II medical device recall Z-0222-2015
Terminated recall by Nidek Inc, reported 2014-11-26, distributed in CA, NE, NY. Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem
| Recall number | Z-0222-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2013-05-24 |
| Classified | 2014-11-17 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2014-11-17 |
| Distributed | CA, NE, NY |
| Quantity | 5 |
| Serial numbers | 50011, 50382, 50425, 50558, 50609 |
Product
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Reason for recall
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
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-0222-2015. 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.