Device recall
Z-1002-2013: Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and…
FDA device recall · Class II · Vital Images, Inc.
Key facts
| Recall number (Z-number) | Z-1002-2013 |
|---|---|
| Recall event | 64461 |
| Product | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital… |
| Product code | LLZ |
| Recalling firm | Vital Images, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2015 |
| 510(k) numbers | K002519 |
| 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