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U.S. Department of Health and Human Services

Class 2 Device Recall INTIO Inc. ClearStartSVM

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 Class 2 Recall
INTIO Inc. ClearStartSVM
see related information
Date Posted March 20, 2013
Recall Status1 Terminated on April 17, 2013
Recall Number Z-0974-2013
Recall Event ID 64435
Premarket Notification
510(K) Number
K113541 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product 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.
Code Information INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
Recalling Firm/
Manufacturer
Intio Inc
325 Interlocken Pkwy
Broomfield, Colorado 80021-3497
For Additional Information Contact Alf Granger
303-396-0291
Manufacturer 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.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
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 support@intio.us or call 303-396-1777. For questions regarding this recall call 303-396-9291.
Quantity in Commerce 7
Distribution Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = INTIO INC.
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