MC-500 Multicolor Laser Photocoagulator — Class II medical device recall Z-1127-2015
Terminated recall by Nidek Inc, reported 2015-02-25, distributed nationwide. The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by its
| Recall number | Z-1127-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2012-03-27 |
| Classified | 2015-02-19 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Serial numbers | 20023, 20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076 |
Product
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Reason for recall
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
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-1127-2015. 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.