Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Publicado el 5 de septiembre de 2012 · Inicio del retiro: 13 de julio de 2009
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
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Toshiba American Medical Systems Inc
- Distribuidor
- Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.
- Lote
- Serial Number: 2DA0882051
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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