• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TheraMap

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall TheraMapsee related information
Date Initiated by FirmDecember 09, 2008
Date PostedJanuary 27, 2009
Recall Status1 Terminated 3 on January 28, 2016
Recall NumberZ-0653-2009
Recall Event ID 50503
510(K)NumberK031350 K050862 
Product Classification tumor mapping software - Product Code LNH
ProductCAD 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 ContactSAME
603-882-5200
Manufacturer Reason
for Recall
Software modules not approved for this indication.
FDA Determined
Cause 2
PMA
ActioniCAD 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 Commerce35
DistributionNationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
-
-