Device recall
Z-2046-2013: NAVIS-EX, Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-2046-2013 |
|---|---|
| Recall event | 65865 |
| Product | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. |
| Product code | HKI |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 25, 2014 |
| 510(k) numbers | K113451 |
| FEI number | 2936921 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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