FDA Device recall Z-0974-2013
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual by Intio, citing INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0974-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-26 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intio |
| Distribution | US |
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.
Reason
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Identifiers
| code_info | INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0974-2013%22
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