BEUDAMED
    FDA Recall Terminated

    CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

    Recall: Z-0654-2009 · Initiated December 9, 2008

    Recall

    Recall Number
    Z-0654-2009
    Event Number
    50503
    Firm
    iCAD, Inc.
    FEI Number
    3026970882
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    December 9, 2008
    Posted
    January 27, 2009
    Terminated
    January 28, 2016
    Address
    4 Townsend W, Ste 17, Nashua, NH, 03063-4220

    Description

    CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

    Reason

    Software modules not approved for this indication.

    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.

    Distribution

    Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.

    Quantity

    35