Device recall
Z-0797-2011: Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX…
FDA device recall · Class II · Vital Images, Inc.
Key facts
| Recall number (Z-number) | Z-0797-2011 |
|---|---|
| Recall event | 57219 |
| Product | Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of… |
| Product code | LLZ |
| Recalling firm | Vital Images, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2012 |
| 510(k) numbers | K072821 |
| 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