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Terminated

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

FDA Recall Z-0654-2009 · Posted 2009-01-27

Recalling FirmiCAD, Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2008-12-09
Date Terminated2016-01-28
Product Quantity35

Reason for Recall

Software modules not approved for this indication.

Firm 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.

Root Cause

PMA

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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