Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications.
Publicado el 30 de julio de 2014 · Inicio del retiro: 30 de junio de 2014
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
Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest , Pixel Lens , Edge enhancement and Histograms . This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel d
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc
- Distribuidor
- Nationwide Distribution
- Lote
- model number: 10496279
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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