FDAFDA · Food and drugs·Recall number 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.
Published November 27, 2013 · Recall initiated: October 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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