Class 2 Device Recall Vivid E9 ultrasound system

• Date Initiated by Firm: October 11, 2013
• Date Posted: November 21, 2013
• Recall Status: Terminated on January 23, 2015
• Recall Number: Z-0373-2014
• Recall Event ID: 66459
• 510(K)Number: K120201
• Product Classification: System, imaging, pulsed echo, ultrasonic - Product Code IYO
• Product: 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.
• Code Information: 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, 0000000VE94599, 0000000VE94600, 0000000VE94601, 0000000VE94602, 0000000VE94603, 0000000VE94604, 0000000VE94605, 0000000VE94607, 0000000VE94608, 0000000VE94609, 0000000VE94610, 0000000VE94611, 0000000VE94612, 0000000VE94613, 0000000VE94614, 0000000VE94616, 0000000VE94617, 0000000VE94618, 0000000VE94621, 0000000VE94623, 0000000VE94624, 0000000VE94627, 0000000VE94628, 0000000VE94629, 0000000VE94630, 0000000VE94631, 0000000VE94633, 0000000VE94634, 0000000VE94635, 0000000VE94636, 0000000VE94645, 0000000VE94646, 0000000VE94647, 0000000VE94648, 0000000VE94649, 0000000VE94650, 0000000VE94651, 0000000VE94652, 0000000VE94653, 0000000VE94654, 0000000VE94655, 0000000VE94656, 0000000VE94657, 0000000VE94658, 0000000VE94659, 0000000VE94673, 0000000VE94674, 0000000VE94681, 0000000VE94682, 0000000VE94683, 0000000VE94685, 0000000VE94686, 0000000VE94687, 0000000VE94688, 0000000VE94689, 0000000VE94690, 0000000VE94691, 0000000VE94692, 0000000VE94693, 0000000VE94694, 0000000VE94697, 0000000VE94706, 0000000VE94707, 0000000VE94708, 0000000VE94709, 0000000VE94710, 0000000VE94711, 0000000VE94719, 0000000VE94720, 0000000VE94721, 0000000VE94722, 0000000VE94723, 0000000VE94724, 0000000VE94725, 0000000VE94726, 0000000VE94727, 0000000VE94728, 0000000VE94729, 0000000VE94730, 0000000VE94732, 0000000VE94733, 0000000VE94735, 0000000VE94736, 0000000VE94737, 0000000VE94738, 0000000VE94740, 0000000VE94741, 0000000VE94743, 0000000VE94744, 0000000VE94745, 0000000VE94746, 0000000VE94747, 0000000VE94748, 0000000VE94749, 0000000VE94750, 0000000VE94751, 0000000VE94752, 0000000VE94753, 0000000VE94761, 0000000VE94762, 0000000VE94763, 0000000VE94764, 0000000VE94765, 0000000VE94766, 0000000VE94767, 0000000VE94768, 0000000VE94769, 0000000VE94770, 0000000VE94782, 0000000VE94783, 0000000VE94784, 0000000VE94785, 0000000VE94786, 0000000VE94787, 0000000VE94788, 0000000VE94789, 0000000VE94790, 0000000VE94791, 0000000VE94792, 0000000VE94793, 0000000VE94794, 0000000VE94795, 0000000VE94796, 0000000VE94800, 0000000VE94801, 0000000VE94802, 0000000VE94803, 0000000VE94804, 0000000VE94805, 0000000VE94808, 0000000VE94809, 0000000VE94825, 0000000VE94826, 0000000VE94827, 0000000VE94828, 0000000VE94832, 0000000VE94833, 0000000VE94838, 0000000VE94839, 0000000VE94840, 0000000VE94841, 0000000VE94846, 0000000VE94854, 0000000VE94855, 0000000VE94856, 0000000VE94859, 0000000VE94860, 0000000VE94861, 0000000VE94862, 0000000VE94863, 0000000VE94865, 0000000VE94866, 0000000VE94869, 0000000VE94870, 0000000VE94873, 0000000VE94874, 0000000VE94875, 0000000VE94876, 0000000VE94877, 0000000VE94883, 0000000VE94884, 0000000VE94885, 0000000VE94886, 0000000VE94887, 0000000VE94888, 0000000VE94889, 0000000VE94890, 0000000VE94891, 0000000VE94895, 0000000VE94896, 0000000VE94897, 0000000VE94898, 0000000VE94899, 0000000VE94900, 0000000VE94901, 0000000VE94902, 0000000VE94903, 0000000VE94904, 0000000VE94905, 0000000VE94906, 0000000VE94907, 0000000VE94912, 0000000VE94913, 0000000VE94914, 0000000VE94915, 0000000VE94916, 0000000VE94917, 0000000VE94918, 0000000VE94923, 0000000VE94924, 0000000VE94925, 0000000VE94926, 0000000VE94927, 0000000VE94928, 0000000VE94929, 0000000VE94930, 0000000VE94931, 0000000VE94932, 0000000VE94933, 0000000VE94934, 0000000VE94935, 0000000VE94936, 0000000VE94940, 0000000VE94941, 0000000VE94942, 0000000VE94943, 0000000VE94944, 0000000VE94948, 0000000VE94949, 0000000VE94950, 0000000VE94951, 0000000VE94952, 0000000VE94953, 0000000VE94954, 0000000VE94955, 0000000VE94957, 0000000VE94958, 0000000VE94959, 0000000VE94965, 0000000VE94966, 0000000VE94967, 0000000VE94968, 0000000VE94969, 0000000VE94970, 0000000VE94971, 0000000VE94972, 0000000VE94973, 0000000VE94974, 0000000VE94975, 0000000VE94976, 0000000VE94977, 0000000VE94978, 0000000VE94979, 0000000VE94980, 0000000VE94981, 0000000VE94982, 0000000VE94983, 0000000VE94984, 0000000VE94985, 0000000VE94989, 0000000VE94990, 0000000VE94991, 0000000VE94992, 0000000VE94993, 0000000VE94994, 0000000VE94995, 0000000VE94996, 0000000VE94997, 0000000VE94998, 0000000VE94999, 0000000VE95000, 0000000VE95001, 0000000VE95002, 0000000VE95003, 0000000VE95004, 0000000VE95011, 0000000VE95012, 0000000VE95013, 0000000VE95014, 0000000VE95015, 0000000VE95016, 0000000VE95019, 0000000VE95022, 0000000VE95023, 0000000VE95024, 0000000VE95025, 0000000VE95026, 0000000VE95027, 0000000VE95028, 0000000VE95029, 0000000VE95034, 0000000VE95035, 0000000VE95036, 0000000VE95037, 0000000VE95038, 0000000VE95043, 0000000VE95044, 0000000VE95045, 0000000VE95049, 0000000VE95050, 0000000VE95051, 0000000VE95052, 0000000VE95053, 0000000VE95058, 0000000VE95060, 0000000VE95061, 0000000VE95062, 0000000VE95068, 0000000VE95069, 0000000VE95083, 0000000VE95084, 0000000VE95085, 0000000VE95086, 0000000VE95087, 0000000VE95088, 0000000VE95089, 0000000VE95090, 0000000VE95091, 0000000VE95092, 0000000VE95093, 0000000VE95094, 0000000VE95095, 0000000VE95096, 0000000VE95097, 0000000VE95098, 0000000VE95100, 0000000VE95101, 0000000VE95104, 0000000VE95110, 0000000VE95122, 0000000VE95123, 0000000VE95124, 0000000VE95125, 0000000VE95126, 0000000VE95127, 0000000VE95128, 0000000VE95129, 0000000VE95130, 0000000VE95137, 0000000VE95138, 0000000VE95139, 0000000VE95146, 0000000VE95147, 0000000VE95152, 0000000VE95153, 0000000VE95154, 0000000VE95155, 0000000VE95156, 0000000VE95157, 0000000VE95158, 0000000VE95160, 0000000VE95161, 0000000VE95162, 0000000VE95163, 0000000VE95164, 0000000VE95165, 0000000VE95166, 0000000VE95167, 0000000VE95174, 0000000VE95180, 0000000VE95181, 0000000VE95182, 0000000VE95183, 0000000VE95194, 0000000VE95195, 0000000VE95196, 0000000VE95202, 0000000VE95206, 0000000VE95207, 0000000VE95208, 0000000VE95209, 0000000VE95210, 0000000VE95211, 0000000VE95212, 0000000VE95220, 0000000VE95221, 0000000VE95222, 0000000VE95223, 0000000VE95224, 0000000VE95225, 0000000VE95226, 0000000VE95228, 0000000VE95229, 0000000VE95230, 0000000VE95231, 0000000VE95232, 0000000VE95233, 0000000VE95246, 0000000VE95247, 0000000VE95248, 0000000VE95249, 0000000VE95250, 0000000VE95251, 0000000VE95252, 0000000VE95253, 0000000VE95254, 0000000VE95255, 0000000VE95259, 0000000VE95260, 0000000VE95261, 0000000VE95262, 0000000VE95263, 0000000VE95264, 0000000VE95265, 0000000VE95266, 0000000VE95269, 0000000VE95270, 0000000VE95271, 0000000VE95272, 0000000VE95273, 0000000VE95274, 0000000VE95275, 0000000VE95276, 0000000VE95277, 0000000VE95278, 0000000VE95279, 0000000VE95294, 0000000VE95295, 0000000VE95296, 0000000VE95298, 0000000VE95299, 0000000VE95300, 0000000VE95301, 0000000VE95302, 0000000VE95303, 0000000VE95304, 0000000VE95305, 0000000VE95306, 0000000VE95307, 0000000VE95308, 0000000VE95309, 0000000VE95310, 0000000VE95311, 0000000VE95312, 0000000VE95318, 0000000VE95319, 0000000VE95320, 0000000VE95321, 0000000VE95331, 0000000VE95332, 0000000VE95333, 0000000VE95334, 0000000VE95335, 0000000VE95343, 0000000VE95344, 0000000VE95345, 0000000VE95346, 0000000VE95347, 0000000VE95365, 0000000VE95366, 0000000VE95367, 0000000VE95370, 0000000VE95371, 0000000VE95372, 0000000VE95377, 0000000VE95378, 0000000VE95379, 0000000VE95380, 0000000VE95382, 0000000VE95383, 0000000VE95384, 0000000VE95385, 0000000VE95386, 0000000VE95387, 0000000VE95388, 0000000VE95389, 0000000VE95390, 0000000VE95391, 0000000VE95392, 0000000VE95393, 0000000VE95394, 0000000VE95395, 0000000VE95396, 0000000VE95405, 0000000VE95406, 0000000VE95407, 0000000VE95411, 0000000VE95412, 0000000VE95413, 0000000VE95414, 0000000VE95415, 000000VE94543.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Component change control
• Action: An Urgent Medical Device Correction letter, dated 10/11/2013, was sent to 3 departments within the affected hospitals. The letter described the safety issue, and identified affected devices. The letter stated to reboot the scanner in an unresponsive /lock up condition. Also if the system is being used for an interventional procedure, the TEE probe should remain in the patient while system is rebooting. A GE healthcare service engineer will install a correction to affected devices.
• Quantity in Commerce: 710
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYO and Original Applicant = GE VINGMED ULTRASOUND AS