Device recall
Z-2132-2014: MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-2132-2014 |
|---|---|
| Recall event | 68766 |
| Product | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. |
| Product code | HQF |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 24, 2014 |
| 510(k) numbers | K110228 |
| FEI number | 2936921 |
At a glance
- 1–9 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