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U.S. Department of Health and Human Services

Class 2 Device Recall PrecisionPoint

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 Class 2 Recall
PrecisionPoint
see related information
Date Posted January 27, 2009
Recall Status1 Open
Recall Number Z-0654-2009
Recall Event ID 50503
Premarket Notification
510(K) Numbers
K031350  K050862 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
Code Information All software versions
Recalling Firm/
Manufacturer
iCAD, Inc.
4 Townsend W Ste 17
Nashua, New Hampshire 03063-4220
For Additional Information Contact SAME
603-882-5200
Manufacturer Reason
for Recall
Software modules not approved for this indication.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action iCAD initiated a voluntary field correction by telephone and letter on 12/5/08 by disabling these features at all affected sites. Since Precision Point and TheraMap are controlled by a software license key, iCAD will disable these features by updating the license at the affected sites.
Quantity in Commerce 35
Distribution Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.
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 = LNH and Original Applicant = 3TP LLC
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