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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62562
Product Type Devices
Status Ongoing
Recalling Firm Varian Medical Systems, Inc. Oncology Systems
City Palo Alto
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including the states of New York and Ohio.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial Numbers/CODES: HIT0535, HIT2953 Class II 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. 2 Units. Z-2153-2012