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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0373-2014

GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

Publicado el 27 de noviembre de 2013 · Inicio del retiro: 11 de octubre de 2013

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 became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare, LLC
Distribuidor
Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Lote
Serial numbers: 0000000VE94166, 0000000VE94167, 0000000VE94170, 0000000VE94171, 0000000VE94172, 0000000VE94173, 0000000VE94174, 0000000VE94175, 0000000VE94176, 0000000VE94177, 0000000VE94178, 0000000VE94179, 0000000VE94180, 0000000VE94181, 0000000VE94182, 0000000VE94183, 0000000VE94184, 0000000VE94185, 0000000VE94186, 0000000VE94187, 0000000VE94188, 0000000VE94190, 0000000VE94191, 0000000VE94192, 0000000VE94193, 0000000VE94194, 0000000VE94195, 0000000VE94196, 0000000VE94197, 0000000VE94198, 0000000VE94199, 0000000VE94210, 0000000VE94211, 0000000VE94212, 0000000VE94213, 0000000VE94214, 0000000VE94215, 0000000VE94216, 0000000VE94217, 0000000VE94225, 0000000VE94226, 0000000VE94227, 0000000VE94231, 0000000VE94232, 0000000VE94233, 0000000VE94234, 0000000VE94235, 0000000VE94236, 0000000VE94237, 0000000VE94238, 0000000VE94243, 0000000VE94244, 0000000VE94245, 0000000VE94246, 0000000VE94247, 0000000VE94248, 0000000VE94249, 0000000VE94250, 0000000VE94251, 0000000VE94252, 0000000VE94253, 0000000VE94254, 0000000VE94263, 0000000VE94268, 0000000VE94270, 0000000VE94280, 0000000VE94281, 0000000VE94285, 0000000VE94286, 0000000VE94287, 0000000VE94288, 0000000VE94289, 0000000VE94290, 0000000VE94291, 0000000VE94292, 0000000VE94293, 0000000VE94294, 0000000VE94295, 0000000VE94296, 0000000VE94297, 0000000VE94299, 0000000VE94300, 0000000VE94301, 0000000VE94302, 0000000VE94303, 0000000VE94305, 0000000VE94306, 0000000VE94307, 0000000VE94314, 0000000VE94315, 0000000VE94316, 0000000VE94317, 0000000VE94318, 0000000VE94319, 0000000VE94327, 0000000VE94328, 0000000VE94329, 0000000VE94330, 0000000VE94331, 0000000VE94332, 0000000VE94333, 0000000VE94334, 0000000VE94340, 0000000VE94349, 0000000VE94350, 0000000VE94351, 0000000VE94353, 0000000VE94354, 0000000VE94355, 0000000VE94356, 0000000VE94357, 0000000VE94358, 0000000VE94359, 0000000VE94361, 0000000VE94362, 0000000VE94363, 0000000VE94364, 0000000VE94365, 0000000VE94366, 0000000VE94367, 0000000VE94368, 0000000VE94372, 0000000VE94373, 0000000VE94374, 0000000VE94375, 0000000VE94377, 0000000VE94378, 0000000VE94387, 0000000VE94388, 0000000VE94389, 0000000VE94390, 0000000VE94393, 0000000VE94395, 0000000VE94396, 0000000VE94398, 0000000VE94399, 0000000VE94400, 0000000VE94408, 0000000VE94409, 0000000VE94410, 0000000VE94420, 0000000VE94421, 0000000VE94422, 0000000VE94423, 0000000VE94424, 0000000VE94426, 0000000VE94427, 0000000VE94428, 0000000VE94429, 0000000VE94430, 0000000VE94431, 0000000VE94432, 0000000VE94433, 0000000VE94439, 0000000VE94440, 0000000VE94451, 0000000VE94452, 0000000VE94453, 0000000VE94454, 0000000VE94455, 0000000VE94456, 0000000VE94457, 0000000VE94458, 0000000VE94459, 0000000VE94460, 0000000VE94462, 0000000VE94463, 0000000VE94464, 0000000VE94465, 0000000VE94466, 0000000VE94477, 0000000VE94478, 0000000VE94479, 0000000VE94480, 0000000VE94482, 0000000VE94483, 0000000VE94484, 0000000VE94485, 0000000VE94486, 0000000VE94487, 0000000VE94488, 0000000VE94489, 0000000VE94490, 0000000VE94491, 0000000VE94492, 0000000VE94497, 0000000VE94498, 0000000VE94499, 0000000VE94500, 0000000VE94501, 0000000VE94502, 0000000VE94503, 0000000VE94508, 0000000VE94510, 0000000VE94512, 0000000VE94519, 0000000VE94524, 0000000VE94525, 0000000VE94526, 0000000VE94527, 0000000VE94528, 0000000VE94529, 0000000VE94530, 0000000VE94531, 0000000VE94532, 0000000VE94533, 0000000VE94534, 0000000VE94535, 0000000VE94536, 0000000VE94537, 0000000VE94538, 0000000VE94539, 0000000VE94540, 0000000VE94541, 0000000VE94542, 0000000VE94544, 0000000VE94545, 0000000VE94546, 0000000VE94547, 0000000VE94548, 0000000VE94549, 0000000VE94550, 0000000VE94551, 0000000VE94561, 0000000VE94562, 0000000VE94563, 0000000VE94564, 0000000VE94566, 0000000VE94567, 0000000VE94568, 0000000VE94569, 0000000VE94570, 0000000VE94571, 0000000VE94572, 0000000VE94574, 0000000VE94578, 0000000VE94579, 0000000VE94580, 0000000VE94582, 0000000VE94583, 0000000VE94584, 0000000VE94585, 0000000VE94591, 0000000VE94594, 0000000VE94595, 0000000VE94596, 0000000VE94597, 0000000VE94598, 0000000VE94
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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