INTIO Inc — Class II medical device recall Z-0974-2013
Terminated recall by Intio Inc, reported 2013-03-27, distributed nationwide. INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promotin
| Recall number | Z-0974-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intio Inc, Broomfield, CO, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2013-03-20 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 7 |
| Reason classes | unapproved product |
| Model numbers | UM-06-20-0003 |
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 for recall
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0974-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.