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Varian Medical Systems, Inc. recalls 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment deliv
Recalled September 24, 2014 · FDA recall Z-2654-2014 · Varian Medical Systems
Hazard
Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV. · FDA Class II
Units
512 affected devices
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macau, Malaysia, Mexico, Netherland,s Portugal, Qutar, Russia, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine and United Kingdom.
Description
Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
Product
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
Manufacturer(s)
Varian Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →