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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2065-2012

OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.

Publicado el 1 de agosto de 2012 · Inicio del retiro: 20 de noviembre de 2006

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

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE OEC Medical Systems, Inc
Distribuidor
Worldwide Distribution - US Nationwide
Lote
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Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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