Company: Varian Medical Systems, Inc.
Date of Enforcement Report: 9/24/2014
Class lI:
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. Recall Number Z-2654-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA on 8/18/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
512
DISTRIBUTION
Nationwide and Internationally.
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