FDAFDA · Alimentos y medicamentos·N.º oficial Z-0721-2017
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Publicado el 14 de diciembre de 2016 · Inicio del retiro: 9 de noviembre de 2016
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
Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- RAYSEARCH LABORATORIES AB
- Distribuidor
- US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington
- Lote
- Build numbers: 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 or 5.0.2.35
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Sweden
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