Device recall
Z-1070-2015: Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture…
FDA device recall · Class II · TeraRecon, Inc.
Key facts
| Recall number (Z-number) | Z-1070-2015 |
|---|---|
| Recall event | 70426 |
| Product | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions… |
| Product code | LLZ |
| Recalling firm | TeraRecon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2015 |
| 510(k) numbers | K121916 |
| FEI number | 3003243710 |
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