CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient resp
FDA device recall Z-0653-2009 · 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3TP WORKSPACE (K050862) | 3tp, LLC | 2005-07-25 |
| 3TP SOFTWARE OPTION (K031350) | 3tp, LLC | 2003-06-23 |