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MAGNETOM Avanto, Espree, Trio A Tim System recallZ-2021-2011 · Siemens Medical Solutions USA, Inc · initiated Mar 3, 2011

Terminated All recalls posted in April 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-2021-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 3, 2011
Posted by the FDA
Apr 18, 2011
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
1419
Product code
LNH
FDA submissions
K013586, K032428, K041112, K050200
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).

Product description

MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

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, 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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, 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Other devices under the same FDA submission

1 device cleared under K013586, K032428, K041112, K050200 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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