Class 2 Device Recall XiO Radiation Treatment Planning System

• Date Initiated by Firm: October 03, 2010
• Date Posted: June 16, 2011
• Recall Status: Terminated on April 03, 2014
• Recall Number: Z-2579-2011
• Recall Event ID: 58197
• 510(K)Number: K092132
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• Product: XiO Radiation Treatment Planning System, XiO Release 4.3.0 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 4.30. and above
• Recalling Firm/ Manufacturer: Computerized Medical Systems Inc; 13723 Riverport Drive; Suite 100; Maryland Heights MO 63043
• For Additional Information Contact: Christopher Ivicevich; 408-830-8000
• Manufacturer Reason for Recall: XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port
• FDA Determined Cause: Software design
• Action: The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice. The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
• Quantity in Commerce: 1208
• Distribution: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, 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, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
• 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.