Company:rian Medical Systems, Inc. Oncology Systemsr
Date of Enforcement Report 8/15/12
Class ll:
PRODUCT
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. Z-2153-2012
REASON
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/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA on 7/2/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
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