MC-500 Multicolor Laser Photocoagulator — Class II medical device recall Z-2132-2014
Terminated recall by Nidek Inc, reported 2014-08-06, distributed nationwide. Laser aperture label was not affixed to device prior to shipment in the US.
| Recall number | Z-2132-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2014-06-09 |
| Classified | 2014-07-30 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2014-11-24 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Serial numbers | 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357, 50358, 50359, 50382, 50383, 50408, 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573 and 4 more |
| Model numbers | 173530U20 |
Product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Reason for recall
Laser aperture label was not affixed to device prior to shipment in the US.
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-2132-2014. 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.