Z-0974-2013 Class II Terminated
FDA device recall Z-0974-2013 was initiated by Intio Inc on February 26, 2013 and is designated Class II. 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. The recall status is terminated (terminated April 17, 2013). Affected quantity: 7.
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