Device recall
Z-1181-2013: Vitrea CT Brain Perfusion made available in various configurations under the…
FDA device recall · Class II · Vital Images, Inc.
Key facts
| Recall number (Z-number) | Z-1181-2013 |
|---|---|
| Recall event | 64833 |
| Product | Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion. |
| Product code | LLZ |
| Recalling firm | Vital Images, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2015 |
| 510(k) numbers | K032748, K121213 |
| FEI number | 3001654007 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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