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U.S. Department of Health and Human Services

Class 2 Device Recall Focal Radiation Treatment Planning System

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 Class 2 Recall
Focal Radiation Treatment Planning System
see related information
Date Posted June 20, 2011
Recall Status1 Terminated on April 02, 2014
Recall Number Z-2592-2011
Recall Event ID 58269
Premarket Notification
510(K) Number
K013112 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
Code Information Focal Release 4.50.00 and above
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall
Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.
FDA Determined
Cause 2
DESIGN: Software Design
Action Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround.
Quantity in Commerce 308
Distribution Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkmenistan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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