Device recall
Z-1980-2014: Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-1980-2014 |
|---|---|
| Recall event | 68234 |
| Product | Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan. |
| Product code | HKI |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2015 |
| 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