CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
This recall has been terminated (originally issued January 27, 2009).
- Company
- Icad, Inc.
- Recall Initiated
- December 9, 2008
- Posted
- January 27, 2009
- Terminated
- January 28, 2016
- Recall Number
- Z-0654-2009
- Quantity
- 35
- Firm Location
- Nashua, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Software modules not approved for this indication.
Distribution
Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.
Lot / Code Info
All software versions
Root Cause
PMA
Action Taken
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.