FDAFDA · Alimentos y medicamentos·N.º oficial Z-2223-2012
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Publicado el 29 de agosto de 2012 · Inicio del retiro: 18 de julio de 2012
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. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Philips Medical Systems (Cleveland) Inc
- Distribuidor
- Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden
- Lote
- System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504 System Code # 728326, Serial #s: 300010, 300030, and 300018
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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