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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 02, 2011
Recall Status1 Terminated on April 10, 2014
Recall Number Z-2407-2011
Recall Event ID 58267
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product XiO Radiation Treatment Planning System, XiO Release 4.50.00 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 4.50.00 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
XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, Elekta, issued an "important Safety Notice" undated, to its customers. The notice indicates the problem and the clinical impact. There is no reasonable workaround for this issue. The notice states a future XiO Release will resolve the issue and the customers will be notified when this solution is available. A return postcard was included with the mailing to verify consignee received the notice. For sites not returning the postcard within one month, the recalling firm will contact them via phone or email to confirm receipt of the notice. The customers were instructed to distribute this notice to any and all users of the CMS software at their organization who are potentially affected by this issue. If you have any questions, please call 314-993-0003 or 800-878-4267.
Quantity in Commerce 415
Distribution Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and Government consignees. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, and United Kingdom.
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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