XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
This recall has been terminated (originally issued June 16, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- September 17, 2010
- Posted
- June 16, 2011
- Terminated
- April 8, 2014
- Recall Number
- Z-2578-2011
- Quantity
- 1293
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t
Distribution
Worldwide distribution: USA (nationwide) including Puerto Rico, and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, 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, North Korea, 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.
Lot / Code Info
XiO Release 4.2.0 and above
Root Cause
Software design
Action Taken
The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites when this solution is available. If you have any questions, please call 314-993-0003 or Toll Free: 800-878-4267.