|
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
|
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
|
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
|
|
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.
|
510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = 3TP LLC
|
|
|
|