Device recall
Z-1131-2010: Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software…
FDA device recall · Class II · Optovue Inc.
Key facts
| Recall number (Z-number) | Z-1131-2010 |
|---|---|
| Recall event | 54191 |
| Product | Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve… |
| Product code | OBO |
| Recalling firm | Optovue Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2011 |
| 510(k) numbers | K091297 |
| 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