Device recall
Z-1494-2017: Final Fit Software Version 1.11 and 1.12; PC Based software installed outside…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-1494-2017 |
|---|---|
| Recall event | 76376 |
| 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… |
| Product code | LZS |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2017 |
| PMA numbers | P970053 |
| FEI number | 2936921 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database