Device recall
Z-2711-2016: SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-2711-2016 |
|---|---|
| Recall event | 74900 |
| Product | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density… |
| Product code | NQE |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2017 |
| 510(k) numbers | K151706 |
| 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