Nidek Excimer Laser Corneal Surgery System — Class II medical device recall Z-0223-2015
Terminated recall by Nidek Inc, reported 2014-11-26, distributed in AZ, CA, CO, CT, FL, LA, ME, MI…. Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery Syst
| Recall number | Z-0223-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2012-08-06 |
| Classified | 2014-11-17 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2014-11-17 |
| Distributed | AZ, CA, CO, CT, FL, LA, ME, MI, MO, NY |
| Quantity | 14 units |
| Serial numbers | 530054, 530055, 530070, 530073, 530078, 530082, 530086, 530087, 530098, 530106, 530121, 530123, 530150, 530155 |
| Model numbers | EC-5000 |
Product
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Reason for recall
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
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-0223-2015. 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.