| Class 2 Device Recall TheraMap | |
Date Initiated by Firm | December 09, 2008 |
Date Posted | January 27, 2009 |
Recall Status1 |
Terminated 3 on January 28, 2016 |
Recall Number | Z-0653-2009 |
Recall Event ID |
50503 |
510(K)Number | K031350 K050862 |
Product Classification |
tumor mapping software - Product Code LNH
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Product | CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. |
Code Information |
All software versions |
Recalling Firm/ Manufacturer |
iCAD, Inc. 4 Townsend W Ste 17 Nashua NH 03063-4220
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For Additional Information Contact | SAME 603-882-5200 |
Manufacturer Reason for Recall | Software modules not approved for this indication. |
FDA Determined Cause 2 | 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 in Commerce | 35 |
Distribution | Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LNH
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