FDAFDA · Alimentos y medicamentos·N.º oficial Z-1920-2019
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
Publicado el 10 de julio de 2019 · Inicio del retiro: 4 de junio de 2019
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
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc
- Distribuidor
- US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI
- Lote
- 106527 106565 106456 106464 106545 106237 106375 106526 106484 106562 106400 106260 106459 106150 106593 106133 106115 106360
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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