Device recall
Z-1144-2013: Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea…
FDA device recall · Class II · Vital Images, Inc.
Key facts
| Recall number (Z-number) | Z-1144-2013 |
|---|---|
| Recall event | 64683 |
| Product | Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional… |
| Product code | LLZ |
| Recalling firm | Vital Images, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 27, 2015 |
| 510(k) numbers | K043333, K052632 |
| 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