—#98281

Product

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K013586, K032428, K041112, K050200
Affected lot / code info: 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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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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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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: 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).

Timeline

Recall initiated: 2011-03-03
Posted by FDA: 2011-04-18
Terminated: 2014-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.