Device recall
Z-1127-2015: MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-1127-2015 |
|---|---|
| Recall event | 70335 |
| Product | MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment. |
| Product code | HQF |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2015 |
| 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