FDAFDA · Alimentos y medicamentos·N.º oficial Z-2819-2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Publicado el 26 de agosto de 2020 · Inicio del retiro: 26 de marzo de 2020
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
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Shanghai United Imaging Healthcare Co., Ltd.
- Distribuidor
- US Nationwide distribution including in the state of TX.
- Lote
- UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- China
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