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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 03, 2011
Recall Status1 Terminated on April 08, 2014
Recall Number Z-2408-2011
Recall Event ID 58205
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code muj
Product XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
Code Information XiO Release 1.0.2 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
When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.
FDA Determined
Cause 2
DESIGN: Software Design
Action Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.
Quantity in Commerce 1377
Distribution Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, 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, 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, Tanzania, 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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