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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 15, 2011
Recall Status1 Terminated on April 08, 2014
Recall Number Z-2574-2011
Recall Event ID 58214
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code muj
Product XiO Radiation Treatment Planning System, XiO Release 1.5.0 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 1.5.0 and above
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall
In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.
FDA Determined
Cause 2
DESIGN: Software Design
Action Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer. The issue was resolved in XiO Release 4.50.00 which has been available since June 2009. A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt. For further questions, please call ( 408) 380-8023.
Quantity in Commerce 936
Distribution Worldwide Distribution -- USA (nationwide) including Puerto Rico, and 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, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, 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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