| Class 2 Device Recall XiO Radiation Treatment Planning System | |
Date Initiated by Firm | November 16, 2010 |
Date Posted | June 17, 2011 |
Recall Status1 |
Terminated 3 on April 03, 2014 |
Recall Number | Z-2582-2011 |
Recall Event ID |
57807 |
510(K)Number | K102216 |
Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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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 of brachytherapy has been prescribed. |
Code Information |
Release 4.50 and higher |
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 408-830-8000 |
Manufacturer Reason for Recall | XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati |
FDA Determined Cause 2 | Other |
Action | Elekta CMS Software drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was distributed to all affected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be available in July 2011. |
Quantity in Commerce | 556 |
Distribution | Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam |
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
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