Events

Device Recall MAGNETOM Avanto, Espree, Trio A Tim System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58080
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2021-2011
  • 사례 시작날짜
    2011-03-03
  • 사례 출판 날짜
    2011-04-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98281
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System Nuclear Magnetic Resonance Imaging - Product Code LNH
  • 원인
    Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. the potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
  • 조치
    Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils. Further questions regarding this recall please call (610) 448-3237.

Device

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
    Radiology Devices
  • 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
    Siemens Medical Solutions USA, Inc

Manufacturer

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