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.
Recall
- Recall Number
- Z-0974-2013
- Event Number
- 64435
- Firm
- Intio Inc
- FEI Number
- 3009138129
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- February 26, 2013
- Posted
- March 20, 2013
- Terminated
- April 17, 2013
- Address
- 325 Interlocken Pkwy, Broomfield, CO, 80021-3497
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.
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
INTIO sent a Recall Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. INTIO has corrected this version of the SVM User's Manual. An INTIO Inc. employee will contact the customers to replace the current manual with the correct one. Consignees were notified by letter that an INTIO Inc. employee will contact you within the next 30 days to replace the current manual with the correct one. The new SVM User's Manual will be provided to you once INTIO Inc. has retrieved the incorrect version of the SVM User's Manual. Customers with questions were instructed to email [email protected] or call 303-396-1777. For questions regarding this recall call 303-396-9291.
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
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