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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 Device Recall XiO Radiation Treatment Planning System see related information
Date Initiated by Firm February 22, 2010
Date Posted March 25, 2010
Recall Status1 Terminated 3 on August 24, 2011
Recall Number Z-1209-2010
Recall Event ID 55008
510(K)Number K092132  
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/
Manufacturer		 Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights MO 63043
For Additional Information Contact Christopher Ivicevich
408-830-8023
Manufacturer Reason
for Recall		 Inconsistent MLC positions, dose, and monitor units
FDA Determined
Cause 2		 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 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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