Device recall
Z-0771-2020: NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides…
FDA device recall · Class III · Nidek, Inc.
Key facts
| Recall number (Z-number) | Z-0771-2020 |
|---|---|
| Recall event | 84112 |
| Product | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, 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, and cell area is analyzed through the… |
| Product code | NQE |
| Recalling firm | Nidek, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 15, 2021 |
| 510(k) numbers | K130565, K151706, K173980 |
| 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