Z-2153-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- July 2, 2012
- Termination Date
- July 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 Units.
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.
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.
Distribution Pattern
Nationwide Distribution including the states of New York and Ohio.
Code Information
Serial Numbers/CODES: HIT0535, HIT2953