XiO Radiation Treatment Planning System, XiO Release 1.5.0 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 15, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- May 14, 2008
- Posted
- June 15, 2011
- Terminated
- April 8, 2014
- Recall Number
- Z-2574-2011
- Quantity
- 936
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.
Distribution
Worldwide Distribution -- USA (nationwide) including Puerto Rico, and 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, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
Lot / Code Info
XiO Release 1.5.0 and above
Root Cause
Software design
Action Taken
Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer. The issue was resolved in XiO Release 4.50.00 which has been available since June 2009. A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt. For further questions, please call ( 408) 380-8023