• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MAGNETOM Avanto, Espree, Trio A Tim System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
MAGNETOM Avanto, Espree, Trio A Tim System
see related information
Date Posted April 18, 2011
Recall Status1 Terminated on December 09, 2014
Recall Number Z-2021-2011
Recall Event ID 58080
Premarket Notification
510(K) Numbers
K013586  K032428  K041112  K050200 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
Code Information 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.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Meredith A. Adams
610-448-3237
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action 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.
Quantity in Commerce 1419
Distribution 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).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
-
-