FDAFDA · Alimentos y medicamentos·N.º oficial Z-1166-2013
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Publicado el 1 de mayo de 2013 · Inicio del retiro: 4 de marzo 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
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips And Neusoft Medical Systems Co., Ltd.
- Distribuidor
- Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
- Lote
- Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- China
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