CLASS II Device recall · Reported 27 Mar 2013 · FDA Enforcement Report
ClearStart-SVM Segmentation recalled by Intio
Intio is recalling Intio Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual, distributed nationwide in the US. The recall was initiated on 26 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0974-2013
- FDA event ID
- 64435
- Recalling firm
- Intio, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2013
- FDA classified
- 20 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 26 Feb 2013 | Recall initiated by company | |
| 20 Mar 2013 | Classified by FDA | +22 days |
| 27 Mar 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Nationwide FloridaMinnesotaNew YorkPennsylvaniaRhode IslandWisconsin
Questions about this recall
Is ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual recalled?
Yes. Intio recalled ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual on 26 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0974-2013.
Why was it recalled?
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Which lots are affected?
INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
Where was it sold?
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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