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U.S. Department of Health and Human Services

Class 2 Device Recall PrecisionPoint

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  Class 2 Device Recall PrecisionPoint see related information
Date Initiated by Firm December 09, 2008
Date Posted January 27, 2009
Recall Status1 Terminated 3 on January 28, 2016
Recall Number Z-0654-2009
Recall Event ID 50503
Product Classification MRI guidance software - 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 NH 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		 PMA
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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