Nidek MC-500 Multicolor Laser Photocoagulator using software version 2 — Class II medical device recall Z-0224-2015
Terminated recall by Nidek Inc, reported 2014-11-26, distributed in CA, IL, IN, MI, MN, NJ, NY, OH…. When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit
| Recall number | Z-0224-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2012-10-24 |
| Classified | 2014-11-17 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2014-11-17 |
| Distributed | CA, IL, IN, MI, MN, NJ, NY, OH, SC, TX, UT |
| Quantity | 21 affected |
| Serial numbers | 50277, 50310, 50311, 50330, 50331, 50357, 50358, 50359, 50382, 50383, 50408, 50417, 50418, 50425, 50426, 50439, 50440, 50445, 50446, 50471, 50514 |
| Model numbers | MC-500 |
Product
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
Reason for recall
When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
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-0224-2015. 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.