CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
FDA device recall Z-0654-2009 · posted 2009-01-27 · Terminated
Recall details
- Recalling firm
- iCAD, Inc.
- Reason for recall
- Software modules not approved for this indication.
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 35
- Distribution
- Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.
- Date initiated
- 2008-12-09
- Date posted
- 2009-01-27
- Date terminated
- 2016-01-28
- Location
- Nashua, NH
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