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Intio Inc recalls INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearS
Recalled March 27, 2013 · FDA recall Z-0974-2013 · Intio
Hazard
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use. · FDA Class II
Units
7
Sold at
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Description
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
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.
Manufacturer(s)
Intio Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →