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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 15, 2011
Recall Status1 Terminated on April 09, 2014
Recall Number Z-2572-2011
Recall Event ID 58233
Premarket Notification
510(K) Number
K013112 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. 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 4.3.1 through 4.34.02
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: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as
FDA Determined
Cause 2
DESIGN: Software Design
Action Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008. The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403) 830-8023.
Quantity in Commerce 307
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, and Venezuela.
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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