Z-0654-2009

CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance

Name: Z-0654-2009 CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance
Creator: iCAD, Inc.
Published: 2008-12-09
License: https://open.fda.gov/license/

iCAD, Inc. / initiated 2008-12-09 / Terminated / root cause: software

FDA source

iCAD, Inc. began a recall of CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance on 2008-12-09. The reason FDA records is "Software modules not approved for this indication". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0654-2009
Status: Terminated
Initiated: 2008-12-09
Posted: 2009-01-27
Terminated: 2016-01-28
Recalling firm: iCAD, Inc.
Product: CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Software modules not approved for this indication.
Root cause tag: software
FDA root 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.
Product codes and lots: All software versions

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)