Reported Mar 27, 2013 · Terminated
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003.…
Intio Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intio Inc · 325 Interlocken Pkwy · Broomfield, CO · 80021-3497
Is this the product you have?
- 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.
- Lot codes and dates
- INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
- Amount recalled
- 7
Where it was sold
Why it was recalled
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
This product could cause temporary or reversible health problems — stop using it.
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