FDAFDA · Food and drugs·Recall number Z-0974-2013
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.
Published March 27, 2013 · Recall initiated: February 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intio Inc
- Distributor
- Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
- Lot
- INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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