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U.S. Department of Health and Human Services

Class 2 Device Recall XiO Radiation treatment Planning System

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 Class 2 Recall
XiO Radiation treatment Planning System
see related information
Date Posted June 16, 2011
Recall Status1 Terminated on April 08, 2014
Recall Number Z-2578-2011
Recall Event ID 58200
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
Code Information XiO Release 4.2.0 and above
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
When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites when this solution is available. If you have any questions, please call 314-993-0003 or Toll Free: 800-878-4267.
Quantity in Commerce 1293
Distribution Worldwide distribution: USA (nationwide) including Puerto Rico, and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
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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