Final Fit Software Version 1 — Class II medical device recall Z-1494-2017
Terminated recall by Nidek Inc, reported 2017-03-29, distributed nationwide. During treatment planning, the procedure was programmed with an unintended (wrong) correction.
| Recall number | Z-1494-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2017-02-01 |
| Classified | 2017-03-20 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
Product
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of 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
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
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-1494-2017. 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.