Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transducer

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


New Search Back to Search Results
 Class 2 Device Recall ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transducersee related information
Date Initiated by FirmMarch 21, 2009
Date PostedApril 12, 2011
Recall Status1 Terminated 3 on March 09, 2012
Recall NumberZ-1961-2011
Recall Event ID 52928
510(K)NumberK063085 
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code ITX
ProductAuxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.
Code Information ACUSON Sequoia serial numbers 50026,  50030,  50042,  50043,  50057,  50087,  50108,  50116,  50172,  50202,  50216,  50243,  50252,  50271,  50279,  50295,  50342,  50355,  50368,  50374,  50418,  50425,  50448,  50493,  50497,  50560,  50561,  50604,  50651,  50676,  50680,  50728,  50777,  50788,  50794,  50796,  50806,  50852,  50855,  50893,  50898,  50920,  50938,  50959,  50964,  51020,  51046,  51055,  51087,  51128,  51185,  51213,  51215,  51229,  51243,  51270,  51278,  51290,  51311,  51332,  51350,  51354,  51367,  51389,  51414,  51433,  51446,  51496,  51498,  51514,  51516,  51523,  51524,  51604,  51636,  51639,  51643,  51652,  51740,  51742,  51747,  51757,  51766,  51781,  51792,  51796,  51800,  51811,  51830,  51844,  51846,  51859,  51897,  51899,  51910,  51920,  51926,  51949,  51955,  51971,  51975,  51979,  51980,  51987,  52003,  52006,  52012,  52023,  52040,  52041,  52047,  52059,  52065,  52075,  52087,  52089,  52101,  52111,  52133,  52136,  52143,  52158,  52170,  52191,  52193,  52195,  52200,  52202,  52243,  52252,  52263,  52272,  52274,  52277,  52282,  52285,  52297,  52307,  52314,  52320,  52322,  52327,  52335,  52346,  52365,  52366,  52375,  52394,  52407,  52410,  52452,  52456,  52475,  52491,  52496,  52504,  52505,  52529,  52559,  52566,  52571,  52572,  52578,  52602,  52604,  52611,  52612,  52629,  52642,  52644,  52645,  52652,  52665,  52683,  52685,  52689,  52694,  52700,  52703,  52704,  52705,  52706,  52708,  52722,  52725,  52735,  52740,  52744,  52750,  52753,  52757,  52768,  52774,  52780,  52794,  52795,  52798,  52800,  52801,  52808,  52811,  52829,  52853,  52865,  52868,  52883,  52906,  52908,  52926,  52936,  52954,  52961,  52966,  52968,  52970,  52997,  53008,  53012,  53024,  53031,  53038,  53039,  53055,  53085,  53095,  53096,  53110,  53123,  53129,  53146,  53156,  53163,  53206,  53226,  53231,  53254,  53262,  53268,  53288,  53290,  53300,  53304,  53313,  53329,  53336,  53344,  53355,  53360,  53400,  53408,  53418,  53434,  53457,  53477,  53486,  53491,  53494,  53501,  53510,  53513,  53518,  53524,  53536,  53542,  53551,  53571,  53576,  53577,  53633,  53635,  53644,  53658,  53662,  53678,  53688,  53709,  53717,  53736,  53739,  53742,  53778,  53781,  53817,  53834,  53877,  53893,  53902,  53914,  53923,  53925,  53932,  53948,  53974,  53987,  54008,  54012,  54014,  54047,  54064,  54069,  54074,  54079,  54082,  54090,  54095,  54102,  54108,  54113,  54134,  54147,  54150,  54156,  54166,  54171,  54177,  54195,  54196,  54205,  54247,  54249,  54250,  54270,  54277,  54279,  54291,  54315,  54320,  54328,  54351,  54360,  54361,  54384,  54397,  54420,  54421,  54432,  54447,  54451,  54457,  54481,  54485,  54499,  54500,  54505,  54509,  54513,  54521,  54528,  54531,  54535,  54540,  54550,  54553,  54558,  54559,  54566,  54567,  54569,  54578,  54588,  54604,  54609,  54648,  54665,  54680,  54692,  54697,  54703,  54708,  54711,  54712,  54719,  54728,  54743,  54784,  54786,  54788,  54793,  54797,  54801,  54842,  54846,  54847,  54855,  54859,  54865,  54879,  54883,  54892,  54893,  54896,  54930,  54933,  54938,  54941,  54948,  54960,  54968,  54972,  54991,  54996,  55000,  55001,  55029,  55039,  55043,  55046,  55051,  55068,  55071,  55080,  55087,  55089,  55103,  55105,  55107,  55112,  55114,  55131,  55155,  55164,  55165,  55169,  55172,  55187,  55199,  55223,  55243,  55246,  55258,  55269,  55270,  55277,  55295,  55298,  55306,  55307,  55317,  55325,  55331,  55337,  55343,  55379,  55399,  55403,  55405,  55406,  55408,  55449,  55457,  55471,  55488,  55489,  55491,  55503,  55507,  55512,  55543,  55555,  55578,  55596,  55600,  55604,  55605,  55609,  55625,  55633,  55656,  55667,  55681,  55694,  55698,  55704,  55729,  55735,  55755,  55769,  55774,  55775,  55797,  55798,  55799,  55811,  55813,  55825,  55841,  55844,  55849,  55855,  55859,  55868,  55917,  55921,  55922,  55929,  55933,  55936,  55942,  55946,  55958,  55962,  55966,  55973,  55981,  55982,  56008,  56033,  56038,  56042,  56051,  56052,  56053,  56080,  56098,  56099,  56101,  56108,  56114,  56142,  56146,  56190,  56192,  56229,  56233,  56237,  56240,  56242,  56253,  56269,  56281,  56283,  56287,  56289,  56290,  56291,  56297,  56303,  56305,  56310,  56316,  56318,  56330,  56335,  56347,  56390,  56397,  56400,  56403,  56414,  56416,  56421,  56424,  56439,  56445,  56447,  56452,  56465,  56474,  56484,  56485,  56487,  56500,  56504,  56530,  56532,  56537,  56538,  56564,  56587,  56590,  56602,  56604,  56605,  56618,  56631,  56658,  56664,  56673,  56684,  56703,  56731,  56735,  56742,  56743,  56756,  56763,  56766,  56767,  56772,  56778,  56778,  56787,  56790,  56812,  56856,  56862,  56876,  56934,  56935,  56953,  56957,  56959,  56970,  56985,  56987,  56992,  56996,  57003,  57005,  57074,  57086,  57090,  57090,  57091,  57113,  57119,  57134,  57138,  57144,  57145,  57153,  57155,  57159,  57171,  57190,  57206,  57215,  57219,  57221,  57247,  57252,  57261,  57286,  57288,  57289,  57311,  57314,  57324,  57331,  57332,  57347,  57348,  57353,  57354,  57361,  57371,  57388,  57395,  57402,  57421,  57427,  57442,  57476,  57483,  57484,  57486,  57489,  57514,  57517,  57519,  57529,  57534,  57539,  57542,  57548,  57552,  57560,  57562,  57579,  57596,  57604,  57606,  57607,  57609,  57611,  59004,  59006,  59017,  59019,  59027,  59035,  59039,  59049,  59053,  59059,  59063,  59109,  59112,  59116,  59120,  59128,  59136,  59140,  59189,  59190,  59192,  59198,  59199,  59203,  59205,  59224,  59228,  59239,  59243,  59254,  59259,  59260,  59262,  59263,  59302,  59318,  59322,  59327,  59331,  60012,  60016,  60029,  60031,  60034,  60055,  60058,  60063,  60064,  60065,  60069,  60076,  60077,  60079,  60083,  60084,  60092,  60095,  60102,  60107,  60111,  60118,  60233,  60234,  60248,  60250,  60253,  60306,  60327,  60331,  60332,  60345,  60351,  60357,  60362,  60364,  60429,  60434,  60439,  60441,  60444,  60452,  60528,  60554,  60556,  60559,  60562,  60566,  60574,  60581,  60585,  60592,  60599,  60606,  60608,  60630,  60636,  60643,  60647,  60687,  60705,  60746,  60778,  60780,  60793,  60798,  60808,  60828,  60830,  60833,  60837,  60840,  60841,  60850,  60851,  60854,  60855,  60858,  60859,  60862,  60867,  60868,  60871,  60874,  60890,  60894,  60905,  60909,  60911,  60912,  61027,  61089,  61099,  61100,  61102,  61113,  61130,  61131,  61134,  61136,  61141,  61142,  61158,  61174,  61183,  61185,  61190,  61192,  61193,  61194,  61196,  61207,  61289,  61295,  61298,  61300,  61302,  61308,  61315,  61317,  61318,  61340,  61342,  61351,  61355,  61377,  61395,  61400,  61412,  61416,  61417,  61420,  61422,  61435,  61437,  61475,  61480,  61494,  61506,  61548,  61556,  61560,  61565,  61570,  61581,  61582,  61589,  61657,  61664,  61704,  61721,  61742,  61748,  61749,  61750,  61754,  61776,  61780,  61783,  61786,  61787,  61789,  61790,  61794,  61796,  61798,  61811,  61812,  61816,  61830,  61831,  61842,  61859,  61861,  61869,  61935,  62004,  62034,  62041,  62042,  62045,  62046,  62048,  62056,  62116,  62124,  62192,  62194,  62199,  62202,  62211,  62215,  62219,  62221,  62230,  62241,  62260,  62261,  62262,  62266,  62276,  62364,  62373,  62379,  62380,  62381,  62407,  62421,  62430,  62434,  62521,  62530,  62531,  62536,  62538,  62541,  62548,  62552,  62560,  62563,  62580,  62587,  62686,  62692,  62697,  62698,  62705,  62717,  62721,  62723,  62729,  62731,  62735,  62737,  62777,  62780,  62785,  62790,  62795,  62843,  62848,  62854,  62856,  62859,  62866,  62868,  62872,  62873,  62878,  62935,  63000,  63003,  63012,  63022,  63027,  63095,  63096,  63098,  63106,  63130,  63141,  63157,  63189,  63193,  63200,  63202,  63210,  63216,  63219,  63278,  63279,  63335,  63346,  63350,  63354,  63356,  63357,  63363,  63370,  63371,  63372,  63378,  63386,  63440,  63447,  63460,  63464,  63466,  63467,  63529,  63534,  63540,  63571,  63574,  63576,  63579,  63582,  63586,  63701,  63704,  63705,  63719,  63722,  63731,  63733,  63735,  63749,  63826,  63830,  63839,  63840,  63843,  63847,  63848,  63850,  63857,  63868,  63879,  63883,  63891,  63893,  63894,  63897,  63901,  63905,  63907,  63908,  63915,  63918,  63930,  63939,  63947,  63972,  63976,  63980,  63985,  63986,  64000,  64003,  64010,  64011,  64012,  64017,  64033,  64077,  64084,  64144,  64160,  64163,  64168,  64199,  64206,  64212,  64235,  64243,  64245,  64246,  64248,  64254,  64258,  64260,  64262,  64286,  64292,  64299,  64300,  64304,  64334,  64339,  64351,  64354,  64356,  64365,  64368,  64372,  64374,  64401,  64403,  64408,  64430,  64440,  64478,  64525,  64544,  64591,  64620,  64634,  64636,  64639,  64651,  64676,  64688,  64700,  64701,  64711,  64725,  64737,  64755,  64759,  64792,  64821,  64829,  64830,  64850,  64853,  64857,  64909,  64911,  64920,  64921,  64927,  64933,  64959,  64960,  64993,  64999,  65001,  65038,  65040,  65050,  65052,  65061,  65080,  65102,  65112,  65137,  65144,  65145,  65178,  65182,  65208,  65209,  65286,  65304,  65312,  65344,  65354,  65362,  65486,  65493,  65525,  65527,  65534,  65594,  65598,  65601,  65602,  65604,  65610,  65614,  65617,  65618,  65624,  65626,  65631,  65632,  65633,  65634,  65635,  65636,  65637,  65638,  65640,  65643,  65646,  65650,  65663,  65666,  65667,  65667,  65668,  65672,  65674,  65675,  65682,  65683,  65683,  65686,  65691,  65693,  65694,  65697,  65698,  65702,  65706,  65707,  65711,  65712,  65718,  65720,  65724,  65725,  65728,  65739,  65750,  65755,  65756,  65793,  65798,  65806,  65812,  65815,  65832,  65842,  65843,  65852,  65860,  65869,  65870,  65872,  65909,  65910,  65917,  65919,  65923,  65927,  65953,  65958,  65959,  65963,  65965,  65966,  65969,  65973,  65975,  65981,  65987,  66011,  66019,  66029,  66035,  66041,  66041,  66076,  66105,  66112,  66133,  66134,  66137,  66138,  66140,  66142,  66150,  66190,  66198,  66210,  66211,  66214,  66229,  66236,  66237,  66239,  66242,  66245,  66248,  66249,  66304,  66313,  66320,  66324,  66336,  66339,  66343,  66345,  66352,  66355,  66378,  66381,  66386,  66394,  66401,  66416,  66420,  66426,  66429,  66431,  66449,  66453,  66460,  66467,  66473,  66476,  66477,  66491,  66495,  66496,  66498,  66499,  66508,  66527,  66528,  66531,  66532,  66545,  66548,  66551,  66575,  66577,  66587,  66594,  66595,  66606,  66610,  66615,  66626,  66630,  66639,  66641,  66645,  66646,  66649,  66653,  66669,  66671,  66674,  66678,  66680,  66681,  66692,  66693,  66699,  66703,  66705,  66710,  66715,  66718,  66720,  66728,  66731,  66734,  66736,  66737,  66742,  66744,  66750,  66752,  66753,  66758,  66759,  66768,  66773,  66779,  66780,  66782,  66787,  66795,  66801,  66804,  66807,  66813,  66818,  66819,  66823,  66825,  66829,  66837,  66851,  66867,  66877,  66886,  66899,  66909,  66913,  66917,  66925,  66927,  66932,  66935,  66947,  66955,  66961,  66977,  66978,  67025,  67029,  67029,  67030,  67042,  67050,  67052,  67053,  67059,  67072,  67075,  67076,  67083,  67086,  67090,  67095,  67099,  67107,  67112,  67117,  67117,  67122,  67125,  67127,  67129,  67130,  67148,  67149,  67150,  67151,  67155,  67157,  67163,  67164,  67167,  67172,  67173,  67180,  67181,  67182,  67185,  67192,  67200,  67200,  67201,  67206,  67207,  67210,  67213,  67215,  67216,  67219,  67221,  67226,  67228,  67235,  67239,  67250,  67256,  67264,  67265,  67276,  67277,  67286,  67292,  67297,  67298,  67299,  67305,  67308,  67317,  67318,  67325,  67328,  67333,  67336,  67337,  67339,  67341,  67345,  67348,  67349,  67351,  67352,  67354,  67355,  67357,  67359,  67360,  67363,  67364,  67365,  67366,  67368,  67371,  67373,  67375,  67377,  67381,  67382,  67390,  67394,  67399,  67401,  67402,  67404,  67408,  67419,  67423,  67424,  67425,  67429,  67431,  67436,  67438,  67439,  67443,  67445,  67446,  67448,  67452,  67463,  67471,  67481,  67485,  67491,  67496,  67500,  67511,  67520,  67557,  67562,  67566,  67568,  67572,  67600,  67605,  67609,  67611,  67622,  67626,  67627,  67638,  67639,  67643,  67644,  67645,  67663,  67664,  67672,  67673,  67676,  67682,  67684,  67688,  67691,  67693,  67694,  67697,  67699,  67701,  67702,  67704,  67705,  67708,  67710,  67712,  67715,  67725,  67727,  67728,  67732,  67733,  67734,  67737,  67740,  67758,  67764,  67769,  67778,  67785,  67790,  67793,  67796,  67801,  67806,  67809,  67814,  67817,  67825,  67828,  67830,  67835,  67837,  67838,  67847,  67849,  67852,  67855,  67856,  67867,  67875,  67876,  67877,  67879,  67887,  67890,  67893,  67895,  67897,  67900,  67901,  67903,  67907,  67908,  67909,  67910,  67912,  67913,  67914,  67915,  67916,  67919,  67921,  67922,  67923,  67924,  67925,  67932,  67933,  67936,  67937,  67939,  67942,  67946,  67947,  67952,  67953,  67954,  67957,  67965,  67967,  67968,  67970,  67973,  67976,  67981,  67982,  67983,  67985,  67986,  67987,  67994,  67995,  67997,  67998,  67999,  68001,  68002,  68003,  68004,  68005,  68007,  68009,  68012,  68013,  68015,  68017,  68020,  68021,  68022,  68026,  68027,  68028,  68029,  68030,  68031,  68032,  68033,  68035,  68036,  68037,  68040,  68042,  68044,  68045,  68047,  68050,  68051,  68054,  68055,  68057,  68059,  68060,  68061,  68062,  68063,  68064,  68064,  68067,  68068,  68069,  68070,  68071,  68072,  68073,  68074,  68075,  68077,  68078,  68080,  68083,  68086,  68088,  68090,  68091,  68094,  68096,  68099,  68102,  68103,  68104,  68116,  68120,  68125,  68126,  68128,  68133,  68136,  68139,  68141,  68142,  68144,  68145,  68146,  68150,  68151,  68152,  68153,  68155,  68156,  68159,  68160,  68161,  68167,  68170,  68171,  68174,  68175,  68178,  68180,  68181,  68182,  68183,  68184,  68185,  68186,  68194,  68200,  68201,  68202,  68203,  68206,  68207,  68209,  68210,  68211,  68213,  68214,  68215,  68216,  68217,  68218,  68219,  68220,  68221,  68225,  68233,  68239,  68240,  68240,  68241,  68242,  68244,  68245,  68246,  68247,  68248,  68251,  68252,  68254,  68257,  68258,  68259,  68260,  68261,  68262,  68263,  68264,  68265,  68268,  68271,  68274,  68275,  68277,  68278,  68281,  68283,  68284,  68286,  68289,  68291,  68292,  68295,  68297,  68301,  68302,  68303,  68305,  68309,  68310,  68312,  68317,  68318,  68321,  68323,  68324,  68326,  68328,  68329,  68329,  68330,  68332,  68333,  68334,  68335,  68338,  68339,  68340,  68341,  68342,  68343,  68344,  68345,  68349,  68351,  68353,  68355,  68357,  68358,  68359,  68360,  68361,  68363,  68364,  68365,  68366,  68367,  68368,  68369,  68370,  68373,  68375,  68376,  68377,  68379,  68381,  68386,  68386,  68387,  68389,  68390,  68391,  68395,  68397,  68400,  68402,  68403,  68404,  68405,  68407,  68408,  68409,  68412,  68413,  68415,  68418,  68420,  68421,  68424,  68426,  68427,  68428,  68439,  68440,  68443,  68444,  68448,  68450,  68450,  68453,  68456,  68460,  68468,  68469,  68470,  68471,  68476,  68477,  68482,  68483,  68484,  68486,  68487,  68488,  68490,  68491,  68493,  68495,  68496,  68497,  68499,  68500,  68501,  68502,  68503,  68504,  68506,  68507,  68508,  68510,  68511,  68512,  68513,  68516,  68517,  68518,  68519,  68520,  68521,  68522,  68523,  68524,  68526,  68531,  68533,  68534,  68540,  68542,  68544,  68546,  68547,  68548,  68553,  68554,  68555,  68557,  68559,  68561,  68562,  68563,  68564,  68566,  68569,  68570,  68571,  68572,  68573,  68574,  68577,  68582,  68583,  68585,  68586,  68587,  68592,  68593,  68595,  68596,  68597,  68598,  68599,  68600,  68601,  68603,  68604,  68605,  68606,  68607,  68608,  68609,  68610,  68611,  68612,  68613,  68614,  68615,  68616,  68618,  68619,  68620,  68621,  68622,  68623,  68626,  68628,  68629,  68631,  68632,  68633,  68634,  68636,  68637,  68639,  68640,  68641,  68642,  68643,  68644,  68651,  68652,  68654,  68655,  68656,  68657,  68660,  68661,  68662,  68663,  68665,  68666,  68668,  68669,  68670,  68675,  68676,  68677,  68678,  68679,  68683,  68684,  68685,  68686,  68689,  68690,  68693,  68695,  68696,  68697,  68698,  68699,  68700,  68701,  68702,  68704,  68705,  68706,  68706,  68708,  68711,  68712,  68713,  68714,  68715,  68716,  68719,  68720,  68722,  68723,  68724,  68725,  68727,  68728,  68729,  68731,  68732,  68733,  68734,  68736,  68739,  68741,  68743,  68744,  68748,  68749,  68750,  68751,  68754,  68755,  68756,  68759,  68760,  68761,  68762,  68763,  68764,  68765,  68766,  68767,  68768,  68770,  68771,  68772,  68773,  68775,  68776,  68778,  68779,  68780,  68781,  68782,  68783,  68785,  68787,  68788,  68789,  68790,  68791,  68792,  68793,  68794,  68795,  68796,  68797,  68798,  68799,  68800,  68801,  68802,  68803,  68804,  68805,  68807,  68808,  68811,  68812,  68814,  68815,  68816,  68817,  68818,  68820,  68821,  68822,  68824,  68826,  68827,  68828,  68829,  68831,  68835,  68837,  68838,  68839,  68840,  68842,  68844,  68846,  68847,  68849,  68850,  68852,  68854,  68857,  68858,  68859,  68861,  68862,  68864,  68865,  68873,  68874,  68875,  68876,  68877,  68878,  68879,  68880,  68881,  68882,  68883,  68884,  68886,  68888,  68889,  68890,  68891,  68892,  68893,  68894,  68895,  68896,  68897,  68899,  68900,  68901,  68902,  68904,  68906,  68907,  68908,  68909,  68910,  68912,  68913,  68914,  68917,  68919,  68921,  68923,  68924,  68925,  68926,  68927,  68928,  68929,  68932,  68933,  68934,  68935,  68937,  68938,  68939,  68940,  68941,  68942,  68943,  68948,  68949,  68950,  68951,  68952, 68956,  68957,  68961,  68966,  68967,  68968,  68969,  68970,  68971,  68973,  68977,  68978,  68983,  68984,  68987,  68988,  68989,  68990,  68992,  68996,  68997,  68998,  69000,  69004,  69005,  69006,  69007,  69008,  69009,  69011,  69012,  69013,  69016,  69018,  69019,  69020,  69021,  69023,  69024,  69025,  69026,  69027,  69028,  69029,  69031,  69034,  69036,  69037,  69039,  69040,  69042,  69044,  69045,  69046,  69047,  69048,  69050,  69052,  69053,  69055,  69056,  69057,  69058,  69059,  69060,  69061,  69062,  69063,  69064,  69065,  69066,  69067,  69068,  69069,  69070,  69072,  69073,  69074,  69076,  69077,  69078,  69079,  69080,  69081,  69083,  69085,  69086,  69088,  69089,  69090,  69091,  69092,  69094,  69095,  69096,  69097,  69098,  69101,  69103,  69104,  69105,  69110,  69112,  69113,  69114,  69116,  69117,  69118,  69120,  69121,  69122,  69123,  69124,  69127,  69128,  69129,  69130,  69131,  69132,  69133,  69134,  69135,  69136,  69138,  69143,  69144,  69145,  69146,  69150,  69151,  69152,  69153,  69154,  69155,  69156,  69157,  69158,  69160,  69161,  69162,  69164,  69166,  69167,  69168,  69169,  69170,  69171,  69173,  69174,  69176,  69177,  69179,  69182,  69184,  69185,  69187,  69189,  69190,  69191,  69192,  69193,  69194,  69195,  69196,  69198,  69200,  69201,  69202,  69204,  69205,  69206,  69207,  69208,  69209,  69210,  69212,  69215,  69216,  69217,  69219,  69221,  69222,  69225,  69226,  69228,  69229,  69230,  69231,  69233,  69236,  69242,  69243,  69244,  69245,  69246,  69249,  69253,  69257,  69258,  69264,  69265,  69268,  69269,  69271,  69272,  69274,  69275,  69276,  69277,  69278,  69279,  69280,  69281,  69284,  69285,  69286,  69287,  69288,  69289,  69291,  69292,  69293,  69294,  69295,  69296,  69298,  69299,  69300,  69301,  69302,  69303,  69304,  69305,  69306,  69307,  69308,  69309,  69311,  69312,  69313,  69314,  69315,  69316,  69318,  69319,  69321,  69322,  69323,  69325,  69326,  69327,  69328,  69329,  69330,  69333,  69335,  69337,  69338,  69340,  69341,  69343,  69344,  69346,  69347,  69348,  69349,  69351,  69352,  69353,  69354,  69355,  69356,  69357,  69358,  69359,  69361,  69362,  69364,  69365,  69366,  69367,  69368,  69369,  69371,  69372,  69374,  69375,  69376,  69377,  69378,  69380,  69381,  69382,  69383,  69384,  69385,  69387,  69389,  69390,  69391,  69392,  69393,  69394,  69395,  69397,  69398,  69399,  69400,  69401,  69402,  69403,  69404,  69405,  69406,  69407,  69408,  69409,  69410,  69411,  69416,  69418,  69419,  69423,  69425,  69426,  69428,  69430,  69431,  69432,  69434,  69438,  69439,  69440,  69441,  69445,  69446,  69447,  69449,  69450,  69451,  69452,  69453,  69456,  69459,  69461,  69462,  69464,  69465,  69466,  69467,  69468,  69469,  69470,  69471,  69475,  69482,  69483,  69485,  69486,  69489,  69490,  69491,  69494,  69495,  69502,  69509,  69519,  69520,  69521,  69522,  65677-1, and 65719-1. 
FEI Number 2936884
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information ContactKristin Dorrough
650-694-5993
Manufacturer Reason
for Recall		Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.
FDA Determined
Cause 2		Software design
ActionThe firm, SIEMENS, sent a "Customer Safety Advisory Notification" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and /or exam type. In addition, the customers were instructed to pass this notice on to all those within their organization who need to be aware of this issue until the corrective action is completed. SIEMENS will release a software update that will correct the issue. The customers local service engineer will install the updates on their system as soon as it becomes available. Should you have any questions regarding this notification, you may contact your local service support person and/or call (650) 969-9112.
Quantity in Commerce2591 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ITX
-
-