Device recall
Z-1498-2016: iVue and iVue 500 (now called iScan) OCT systems with software version…
FDA device recall · Class II · Optovue, Inc.
Key facts
| Recall number (Z-number) | Z-1498-2016 |
|---|---|
| Recall event | 73612 |
| Product | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and… |
| Product code | HLI |
| Recalling firm | Optovue, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2017 |
| 510(k) numbers | K121739, 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