Device recall
Z-1636-2015: MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma…
FDA device recall · Class II · MELA Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-1636-2015 |
|---|---|
| Recall event | 71127 |
| Product | MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection. |
| Product code | OYD |
| Recalling firm | MELA Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 4, 2016 |
| PMA numbers | P090012 |
| FEI number | 3002942014 |
At a glance
- None 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