Device recall
Z-0008-2018: iVue with Normative Database, Device Listing Number D185549. Product Usage: The…
FDA device recall · Class II · Optovue, Inc.
Key facts
| Recall number (Z-number) | Z-0008-2018 |
|---|---|
| Recall event | 77776 |
| Product | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a 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… |
| Product code | HLI |
| Recalling firm | Optovue, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2021 |
| 510(k) numbers | K121739 |
| 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