FDAFDA · Alimentos y medicamentos·N.º oficial Z-1275-2014
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.
Publicado el 2 de abril de 2014 · Inicio del retiro: 25 de julio de 2013
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
An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Velocity Medical Solutions, LLC
- Distribuidor
- Worldwide Distribution - US (nationwide) including the states of AL, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MS, NC, NY, PA, SC, TN, TX, WI, and the countries of Belarus, Italy and Switzerland.
- Lote
- VelocityAIS 3.0.0
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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