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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2240-2012

892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.

Publicado el 29 de agosto de 2012 · Inicio del retiro: 6 de noviembre de 2009

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

GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE OEC Medical Systems, Inc
Distribuidor
Worldwide Distribution -- USA (nationwide)
Lote
Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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