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.
FDA Recall Z-2592-2011 · Posted 2011-06-20
Advertisement
Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-05-10
Date Terminated2014-04-02
Product Quantity308
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement