FDAFDA · Alimentos y medicamentos·N.º oficial Z-1295-2019
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Publicado el 15 de mayo de 2019 · Inicio del retiro: 22 de marzo 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
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc
- Distribuidor
- US Nationwide Distribution in the states of NC, MA
- Lote
- Cios Alpha system with SW VA30
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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