FDAFDA · Alimentos y medicamentos·N.º oficial Z-3093-2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Publicado el 6 de septiembre de 2017 · Inicio del retiro: 18 de febrero de 2016
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
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc
- Distribuidor
- Nationwide Distribution
- Lote
- Artis zee biplane MN- Serial number: 149402 149401
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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