Device Recall MAGNETOM Avanto, Espree, Trio A Tim System

  • 모델명 / 제조번호(시리얼번호)
    Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. Serial numbers 30265, 30204, 35108, 30646, 35020, 25297, 30125, 30234, 30435, 30385, 26326, 30317, 30476, 35258, 30019, 30130, 30035, 30851, 30475, 30759, 26182, 30833, 25635, 30162, 25998, 35227, 30153, 35012, 30226, 30028, 30380, 30045, 30202, 25300, 25880, 30108, 25758, 30799, 30616, 30767, 30940, 26213, 30426, 27213, 35161, 31089, 25492, 26566, 35299, 25242, 25293, 30504, 35330, 30454, 30233, 30338, 30529, 30208, 30740, 30482, 30472, 30383, 26425, 30364, 30499, 30275, 30834, 26698, 30254, 26223, 26329, 30124, 30512, 30166, 30410, 26553, 25409, 35015, 26900, 30602, 30957, 30144, 30780, 30896, 30239, 30839, 30250, 30298, 30083, 30730, 30986, 30367, 30109, 35064, 30225, 31000, 30857, 30440, 30012, 30350, 35318, 35319, 35321, 26491, 30471, 30242, 30948, 30337, 30392, 30582, 30058, 35403, 25911, 30938, 30474, 30732, 27641, 30601, 25134, 35259, 25717, 25420, 20600, 27633, 35111, 26364, 30391, 27175, 25154, 25424, 30056, 30742, 26194, 30959, 30300, 30830, 30353, 30777, 30201, 35312, 35311, 26504, 30887, 27260, 30958, 31033, 35176, 30238, 30176, 35077, 30652, 35408, 27101, 30273, 35222, 30925, 30090, 25852, 30272, 25230, 30032, 25264, 35152, 25991, 30066, 25286, 31001, 26016, 26272, 30753, 27013, 30224, 30720, 35380, 30607, 30633, 31015, 35010, 25215, 25427, 25962, 27505, 30783, 26077, 30112, 31039, 25316, 35364, 26230, 27157, 25716, 30627, 26145, 30039, 30346, 25054, 26358, 35235, 35182, 26031, 35201, 25948, 30255, 35008, 35014, 25069, 25408, 26657, 26953, 27162, 25931, 26252, 27156, 25063, 26827, 26088, 25672, 25179, 25976, 25114, 25893, 25395, 30689, 30569, 30402, 25888, 30650, 25552, 25231, 30811, 30539, 30705, 30059, 30960, 30982, 35261, 35029, 25389, 25730, 25768, 26856, 30656, 30137, 30628, 30591, 35050, 30017, 30249, 30132, 30782, 35351, 26726, 25678, 30180, 30622, 27316, 25905, 25582, 25166, 30597, 30992, 25921, 25551, 25491, 30388, 25310, 30481, 30256, 30401, 30647, 26465, 27051, 25651, 30791, 30635, 25818, 26187, 30552, 26668, 35348, 30468, 30452, 30348, 25507, 30962, 27079, 26762, 26764, 30424, 30119, 25576, 30549, 26359, 31094, 30111, 30161, 30880, 30846, 30291, 30347, 30187, 30015, 30453, 30478, 25680, 30614, 30040, 25404, 25484, 27306, 26114, 26121, 25807, 30072, 35163, 30590, 30837, 26436, 30524, 35046, 26244, 27707, 25445, 35125, 30542, 35110, 25108, 30550, 30838, 30441, 35221, 30422, 30803, 35398, 30506, 35167, 25429, 25292, 30443, 30534, 30596, 25663, 25992, 27019, 25352, 25386, 35025, 26356, 31020, 25505, 30564, 30528, 30386, 25207, 26141, 25438, 25444, 26360, 30357, 25960, 26311, 26280, 30670, 26792, 25025, 30770, 26171, 25993, 25525, 30360, 30488, 25145, 30613, 30972, 30733, 30662, 30985, 25307, 25364, 30570, 25682, 30171, 35172, 25977, 30258, 30771, 27376, 30036, 30487, 30723, 30598, 30370, 30044, 30316, 30247, 31074, 25523, 35052, 25489, 26591, 26062, 26653, 30175, 30669, 31013, 25459, 25785, 30868, 30618, 26287, 26383, 30800, 30459, 27252, 35186, 26078, 30758, 30089, 30553, 25572, 30810, 26779, 35389, 30376, 25796, 35358, 26281, 30557, 30793, 30879, 31072, 25175, 26224, 35323, 27347, 30750, 26446, 35250, 30467, 30522, 26665, 30408, 30375, 30991, 35240, 30115, 30561, 26619, 30721, 31023, 30145, 25877, 30587, 30866, 35157, 30063, 30359, 30182, 30711, 26398, 26888, 30743, 26217, 25967, 26897, 27426, 25696, 25196, 30345, 25763, 25041, 30497, 26617, 30136, 30122, 30207, 35160, 30014, 30438, 30381, 30491, 30844, 31046, 30304, 30823, 30935, 30719, 30910, 30832, 30623, 30462, 30445, 31084, 31049, 30068, 35062, 25058, 35043, 30076, 30968, 25520, 25771, 30362, 26168, 30295, 30685, 27177, 26442, 26649, 27451, 30369, 30663, 27366, 31036, 30054, 30503, 30544, 30530, 30749, 30966, 30460, 27180, 60600, 30738, 25978, 25985, 30287, 30817, 35192, 35236, 25497, 26269, 30798, 31012, 30448, 30518, 31059, 25203, 30220, 30593, 30069, 25332, 30565, 30904, 30951, 25720, 26945, 26785, 34144, 31041, 30463, 30080, 30179, 30413, 25105, 30520, 30021, 26881, 30029, 26621, 30065, 30071, 25927, 30407, 30061, 30248, 30509, 26533, 26400, 30227, 35280, 35281, 25104, 31092, 35317, 25337, 26053, 35180, 30169, 30197, 30211, 31098, 30319, 30067, 25460, 27344, 30915, 30661, 30559, 25606, 30320, 30423, 30870, 26126, 35115, 30451, 35101, 35288, 35022, 25157, 26039, 30005, 30082, 25581, 25973, 26051, 266227, 30525, 25533, 25411, 25817, 25558, 35070, 26399, 35023, 30563, 30271, 30043, 30210, 25021, 30206, 30378, 30536, 35307, 30228, 25610, 30632, 26966, 26449, 30680, 31065, 26938, 30146, 30170, 25044, 30676, 30297, 30765, 26080, 35074, 26423, 30994, 30703, 25284, 26397, 31008, 26435, 26870, 27059, 30447, 25077, 26286, 27179, 25926, 30264, 30638, 30763, 35428, 35066, 25822, 30643, 25322, 25384, 26846, 25875, 25126, 27161, 30241, 30989, 30548, 35164, 27053, 35141, 30936, 26963, 30398, 25152, 30185, 30515, 35162, 35006, 25096, 30588, 35238, 27054, 30787, 30049, 26992, 25225, 30490, 35295, 30806, 30232, 30342, 30864, 30523, 30074, 30577, 25550, 25957, 25358, 30340, 25701, 30675, 25249, 30824, 30368, 30414, 27467, 30876, 35007, 25036, 25727, 25952, 30581, 30277, 30639, 30668, 30366, 30142, 30621, 20587, 27297, 30748, 30216, 30775, 25470, 30025, 26255, 26418, 30425, 30430, 30404, 25146, 30400, 30924, 35104, 30814, 30470, 35390, 30308, 25135, 26216, 26704, 31034, 30592, 30148, 30756, 26620, 26193, 30869, 25454, 30075, 31005, 30917, 30953, 30975, 30943, 30918, 30946, 25783, 25797, 35279, 25030, 35001, 20591, 25010, 25403, 30786, 35423, 30263, 30651, 31060, 31053, 30096, 25910, 27354, 30872, 30094, 25594, 30952, 30768, 30150, 30269, 26373, 35187, 26692, 30789, 26350, 31018, 25352, 26241, 30997, 25174, 30349, 30305, 26454, 30106, 30389, 30508, 35427, 35013, 25023, 26461, 27324, 30726, 30828, 27471, 26052, 35075, 25792, 25949, 30326, 25383, 26957, 27040, 30507, 27194, 31067, 30095, 30510, 25274, 30713, 30047, 30167, 30871, 30728, 30081, 30855, 27204, 30023, 26325, 30266, 30302, 30103, 35271, 35139, 30289, 35078, 30100, 30543, 30862, 30858, 30235, 30406, 25527, 30697, 30151, 35136, 35131, 31086, 27244, 30437, 25477, 30325, 30708, 30154, 30363, 30978, 30874, 30617, 30784, 35385, 26804, 30585, 30664, 30667, 30578, 26011, 27293, 31083, 30160, 30261, 30428, 25372, 30725, 30631, 30558, 30343, 30772, 30377, 35393, 30746, 30502, 30418, 25530, 26489, 26590, 26723, 30229, 30849, 35212, 30473, 26486, 26333, 25903, 30282, 25342, 30446, 25412, 30236, 30630, 26670, 26546, 35048, 26370, 30484, 27100, 30055, 30433, 30379, 30129, 30555, 26627, 30306, 30571, 25961, 30020, 30114, 30116, 25180, 25305, 25690, 30009, 25185, 26004, 30458, 30717, 25919, 30744, 30107, 30541, 30371, 25123, 30533, 25614, 26314, 30745, 30580, 31104, 30214, 25980, 26319, 25684, 27534, 30361, 30033, 30231, 26048, 26130, 26628, 30949, 30673, 30138m 27046, 30575, 26371, 35191, 25435, 30140, 26927, 27198, 25833, 35026, 30629, 25479, 26021, 30535, 30046, 30477, 30854, 25247, 31022, 30152, 30372, 25537, 27253, 30091, 27099, 31341, 30684, 30358, 35011, 26064, 30420, 35243, 26568, 26959, 25216, 26808, 26427, 27443, 30276, 30479, 30773, 35297, 26243, 25958, 35264, 30373, 26559, 30223, 35324, 30956, 30781, 30434, 30605, 35168, 30609, 30149, 30642, 30027, 30262, 30988, 30159, 30042, 26075, 35005, 35171, 25150, 35019, 30945, 31100, 30483, 25772, 30526, 30164, 25222, 30415, 26462, 27620, 27557, 30030, 25164, 27004, 25093, 30566, 26835, 30419, 30092, 30158, 30974, 30449, 25644, 27381, 30034, 30057, 26037, 25815, 30574, 30230, 30314, 26159, 35284, 26148, 26178, 30163, 30268, 30352, 25485, 30399, 26284, 30053, 25382, 30022, 26276, 25374, 25837, 25298, 27207, 27714, 25899, 30812, 25074, 25946, 26662, 30270, 31087, 25078, 27033, 30313, 30501, 25155, 26026, 30365, 27330, 35290, 30498, 26532, 25509, 27222, 30239, 30356, 25240, 30155, 31071, 30779, 35018, 25718, 26689, 31097, 35184, 35045, 27102, 35188, 30253, 25070, 25767, 26560, 30191, 30301, 35153, 26615, 25436, 30198, 26155, 25528, 20573, 25248, 30442, 27201, 25430, 26956, 30267, 27088, 27066, 25959, 25038, 30916, 30290, 25705, 30064, 35241, 30084, 30190, 30037, 30395, 25046, 26469, 30296, 30604, 25372, 30665, 30344, 26018, 31032, 30293, 25087, 35344, 26569, 30845, 31014, 25033, 26451, 30060, 35365, 25245, 26219, 30396, 35445, 30240, 30024, 26885, 30931, 25681, 30456, 30485, 30822, 25707, 30625, 25086, 35357, 25362, 25625, 25694, 30041, 25024, 35230, 30279, 26452, 30004, 30311, 31080, 30085, 35328, 26320, 35343, 35003, 25016, 35260, 25212, 27595, 35426, 30141, 25969, 30843, 25511, 26191, 30079, 30480, 26575, 30411, 30829, 35412, 25140, 25106, 26550, 27230, 30836, 30118, 27122, 35035, 35030, 25712, 26109, 25611, 35273, 25052, 30086, 30809, 35257, 27049, 30196, 30178, 30769, 35114, 25347, 35229, 35068, 35044, 25963, 26811, 35053, 30653, 35267, 35024, 25706, 25870, 27214, 25029, 30121, 30671, 35072, 35142, 25233, 25776, 35021, 30429, 35338, 25320, 35335, 35069, 30194, 35154, 25886, 35067, 35039, 25198, 30165, 35327, 35061, 30427, 30128, 35263, 35017, 25820, 35313, 26564, 35228, 25360, 31006, 25457, 30382, 25725, 25047, 30551, 30595, 30692, 25539, 25580, 25654, 26396, 26421, 27358, 30120, 30200, 26751, 30143, 30937, 30831, 35216, 35217, 35073, 30193, 27050, 25814, 30942, 30412, 30516, 30734, 30825, 30848, 30941, 31021, 31056, 35291, 35418, 25350, 25381, 25667, 25675, 26054, 26248, 26492, 26608, 26652, 26787, 26893, 27221, 27258, 27412, 26424, 30299, 30436, 30666, 30674, 30928, 25508, 26648, 26781, 26962, 30926, 30990, 26214, 20616, 26852, 30374, 25453, 30173, 25144, 26125, 26535, 30221, 27637, 30243, 35443, 35439, 35444, 30619, 25232, 26192, 30556, 30213, 25065, 25432, 30710, 25734, 30469, 30511, 26972, 30354, 25103, 25956, 30658, 35177, 35248, 26321, 30283, 25912, 35415, 30922, 30192, 30310, 31025, 26747, 25510, 30126, 30612, 25390, 25197, 30390, 30626, 35155, 26614, 27172, 30199, 30881, 35174, 25800, 25540, 30339, 30724, 25693, 30955, 26132, 30186, 25816, 30659, 31052, 26937, 30038, 30246, 25609, 30093, 30464, 26998, 30774, 27224, 30785, 27026, 35407, 35071, 35076, 30123, 30203, 30281, 30387, 30409, and 30181.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY(every State except VT).
  • 제품 설명
    MAGNETOM Avanto, Espree, Trio A Tim System. || Nuclear magnetic resonance imaging.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
  • Source
    USFDA