Device recall
Z-1441-2013: Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1…
FDA device recall · Class III · Optovue, Inc.
Key facts
| Recall number (Z-number) | Z-1441-2013 |
|---|---|
| Recall event | 65191 |
| Product | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. |
| Product code | HLI |
| Recalling firm | Optovue, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 24, 2013 |
| 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