iCAD, Inc. CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
Brand
iCAD, Inc.
Lot Codes / Batch Numbers
All software versions
Products Sold
All software versions
iCAD, Inc. is recalling CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance. due to Software modules not approved for this indication.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software modules not approved for this indication.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026