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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 March 25, 2010
Recall Status1 Terminated on August 24, 2011
Recall Number Z-1209-2010
Recall Event ID 55008
Premarket Notification
510(K) Number
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product XiO Radiation Treatment Planning System, Release 4.51.00.
Code Information Release 4.51.00
Recalling Firm/
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
For Additional Information Contact Christopher Ivicevich
Manufacturer Reason
for Recall
Inconsistent MLC positions, dose, and monitor units
FDA Determined
Cause 2
DESIGN: Software Design
Action Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
Quantity in Commerce Planning system is loaded 25 in locations
Distribution Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
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.