FDAFDA · Alimentos y medicamentos·N.º oficial Z-2153-2012
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.
Publicado el 15 de agosto de 2012 · Inicio del retiro: 2 de julio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Varian Medical Systems, Inc. Oncology Systems
- Distribuidor
- Nationwide Distribution including the states of New York and Ohio.
- Lote
- Serial Numbers/CODES: HIT0535, HIT2953
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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