EC-5000 Excimer Laser Corneal Surgery System — Class II medical device recall Z-1710-2015
Terminated recall by Nidek Inc, reported 2015-06-10. Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
| Recall number | Z-1710-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2015-03-24 |
| Classified | 2015-06-04 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-04-05 |
| Quantity | 114 units |
| Reason classes | unapproved product |
| Model numbers | EC-5000 |
Product
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Reason for recall
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
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-1710-2015. 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.