Device recall
Z-0024-2013: Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped…
FDA device recall · Class II · Optovue Inc.
Key facts
| Recall number (Z-number) | Z-0024-2013 |
|---|---|
| Recall event | 63211 |
| Product | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont… |
| Product code | OBO |
| Recalling firm | Optovue Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2013 |
| 510(k) numbers | K091404, K101505 |
| FEI number | 3005950902 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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