SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
Publicado el 3 de octubre de 2012 · Inicio del retiro: 10 de octubre de 2011
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
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc)
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- RAYSEARCH LABORATORIES AB
- Distribuidor
- Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
- Lote
- version 1.2.1 (build number 1.3.1.10).
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Sweden
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