Drug recall
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser…
FDA recall event 76376 · Class II · Nidek Inc
Key facts
| Event ID | 76376 |
|---|---|
| Recall numbers | Z-1494-2017 |
| Recalling firm | Nidek Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During treatment planning, the procedure was programmed with an unintended (wrong) correction. |
| Initiation date | Feb 1, 2017 |
| Report date | Mar 29, 2017 |
| Termination date | Dec 5, 2017 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 2936921 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: