Device recall
Z-0010-2018: iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic…
FDA device recall · Class II · Optovue, Inc.
Key facts
| Recall number (Z-number) | Z-0010-2018 |
|---|---|
| Recall event | 77776 |
| Product | iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion… |
| Product code | HLI |
| Recalling firm | Optovue, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2021 |
| 510(k) numbers | K133892 |
| FEI number | 3005950902 |
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