Device recall
Z-0974-2013: INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users…
FDA device recall · Class II · Intio Inc
Key facts
| Recall number (Z-number) | Z-0974-2013 |
|---|---|
| Recall event | 64435 |
| Product | INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment. |
| Product code | LLZ |
| Recalling firm | Intio Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2013 |
| 510(k) numbers | K113541 |
| FEI number | 3009138129 |
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