Class 2 Device Recall PrecisionPoint

• Date Initiated by Firm: December 09, 2008
• Date Posted: January 27, 2009
• Recall Status: Terminated 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: 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.