Z-0974-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2013
- Initiation Date
- February 26, 2013
- Termination Date
- April 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
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.
Distribution Pattern
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Code Information
INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual