FDAFDA · Alimentos y medicamentos·N.º oficial Z-1155-2024
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
Publicado el 28 de febrero de 2024 · Inicio del retiro: 15 de noviembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Canon Medical System, USA, INC.
- Distribuidor
- US: CA, LA
- Lote
- UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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