Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
This recall has been terminated (originally issued June 20, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- May 10, 2010
- Posted
- June 20, 2011
- Terminated
- April 2, 2014
- Recall Number
- Z-2592-2011
- Quantity
- 308
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.
Distribution
Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkmenistan.
Lot / Code Info
Focal Release 4.50.00 and above
Root Cause
Software design
Action Taken
Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround.