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.
FDA Recall Z-0974-2013 · Posted 2013-03-20
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Recalling FirmIntio Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-02-26
Date Terminated2013-04-17
Product Quantity7
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.
Firm Action
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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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