03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. [Code Info] Serial Numbers/CODES: HIT0535, HIT2953 [Reason for Recall] A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. [Recalling Firm] Varian Medical Systems, Inc. Oncology Systems [Classification] 
Class II
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012