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Class 2 Device Recall XiO Radiation Treatment Planning System |
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Date Initiated by Firm |
May 28, 2010 |
Date Posted |
June 20, 2011 |
Recall Status1 |
Terminated 3 on April 10, 2014 |
Recall Number |
Z-2595-2011 |
Recall Event ID |
58260 |
510(K)Number |
K092132
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Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product |
XiO Radiation Treatment Planning System, XiO Release 4.0.2 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 4.0.2 and above |
Recalling Firm/ Manufacturer |
Computerized Medical Systems Inc 13723 Riverport Drive Suite 100 Maryland Heights MO 63043
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For Additional Information Contact |
Christopher Ivicevich 408-380-8023
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Manufacturer Reason for Recall |
XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had always been done manually by the user. This is functionality that has never been provided on XiO. The problem occurs because XiO is not storing a persistent DICOM
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FDA Determined Cause 2 |
Software design |
Action |
Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available.
No date was given for the mailing or the solution. |
Quantity in Commerce |
1292 |
Distribution |
Worldwide Distribution - USA (Nationwide distribution, including Washington, DC 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, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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