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U.S. Department of Health and Human Services

Class 2 Device Recall FOCAL Workstation

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  Class 2 Device Recall FOCAL Workstation see related information
Date Initiated by Firm February 06, 2009
Date Posted June 20, 2011
Recall Status1 Terminated 3 on April 08, 2014
Recall Number Z-2599-2011
Recall Event ID 58250
510(K)Number K013112  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00.

Product Usage: 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 4.1.1 through 4.40.00
Recalling Firm/
Manufacturer		 Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights MO 63043
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall		 Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to
FDA Determined
Cause 2		 Software design
Action Elekta CMS Software sent an "ADVISORY NOTICE" dated February 6, 2009 to its affected customers. The notice identified the product, the problem, and the actions to be taken. Customers were informed that the workaround method available is to (edit the MLC pattern using the aperture first and the individual MLC leaf edits second). The firm states that this issue will be resolved in Focal version 4.50.00 and above. A "User Notice" will be sent to all users still using the affected software notifying them of the updated software available to correct the problem. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
Quantity in Commerce 760
Distribution Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, Uruguay and Venezuela.
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 = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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