Device recall
Z-1004-2011: Optovue iVue optical coherence tomography system, computer controlled opthalmic…
FDA device recall · Class II · Optovue Inc.
Key facts
| Recall number (Z-number) | Z-1004-2011 |
|---|---|
| Recall event | 56759 |
| Product | Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The… |
| Product code | NQQ |
| Recalling firm | Optovue Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2011 |
| 510(k) numbers | K091404 |
| 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