GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser… — Class II medical device recall Z-2120-2014
Terminated recall by Nidek Inc, reported 2014-08-20, distributed nationwide. Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as
| Recall number | Z-2120-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2014-05-16 |
| Classified | 2014-08-13 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2014-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 567 units |
| Reason classes | labeling |
| Serial numbers | 10018, 10039, 10040, 10041, 10042, 10043, 10044, 10045, 10046, 10047, 10048, 10063, 10064, 10066, 10067, 10068, 10072, 10073, 10074, 10075, 10079, 10080, 10081, 10082, 10083 and 475 more |
| Model numbers | 1000, GYC-1000 |
Product
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Reason for recall
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
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-2120-2014. 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.