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.
This recall has been terminated (originally issued June 20, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- May 28, 2010
- Posted
- June 20, 2011
- Terminated
- April 10, 2014
- Recall Number
- Z-2595-2011
- Quantity
- 1292
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
XiO Release 4.0.2 and above
Root Cause
Software design
Action Taken
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.