XiO Radiation Treatment Planning System, XiO Release 1.0.2 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 3, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- September 10, 2010
- Posted
- June 3, 2011
- Terminated
- April 8, 2014
- Recall Number
- Z-2408-2011
- Quantity
- 1377
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.
Distribution
Worldwide Distribution - USA (nationwide 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, 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, 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, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
Lot / Code Info
XiO Release 1.0.2 and above
Root Cause
Software design
Action Taken
Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.