Recall Z-0654-2009 ยท LNH System, Nuclear Magnetic Resonance Imaging
iCAD, Inc.
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
| Date | Jan 27, 2009 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | Software modules not approved for this indication. |
| 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 | 35 |
| Distribution | Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.