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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 10, 2014
Recall Number Z-2596-2011
Recall Event ID 58256
Premarket Notification
510(K) Number
K013112 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 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 4.3.0 through 4.34.01
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
For Additional Information Contact Christopher Ivicevich
314-993-0003
Manufacturer Reason
for Recall
Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (col
FDA Determined
Cause 2
DESIGN: Software Design
Action Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.
Quantity in Commerce 233
Distribution Worldwide Distribution - USA (Nationwide AL, AR, CA, DE, FL, GA, IL, IN, MA, MD, MI, MOP, NE, NY, OH, PA, RI, TX, VA, WA, WI, and WV and the countries of Albania, Argentina, Belgium, Bosnia and Herzegovina, Brazil, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, 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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