SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,

Summary

The FDA issued a Class II for SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to D by GE Medical Systems, LLC. Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scannin.

Details

Product Description

SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Lot/Code Info: System ID: 907373MR, 2058773T, 251435MR3T, 480507MR2, 928475MR1, SMITOMARC, 928348MR, 480425MR10, 510SHARMR, 310680DVMR, 213825DVMR4, 510HHARCMR, SMCARC3TMR, 510204ARMR, 415723SHMR22, 415723CHMR5, 925734ARMR, 650723NCMR3, UCDACC3TMR, 415CPCHMR1, 415CPCHMR2, RADNETMR635, 720848MR3, 303467MR2, 719333MR3T, 203739DDI3T, 860679750W, 302733MR3T, 352VAMR3T, 904223MR2, 904202MR15, 904202MR14, 561747MR3, 904VA3T, 850494MR3T, 772VRAMR3TARCH, 4046053TMR, 47830TMR, 912819MR, 630893MR, 630DMGMR3T, 312355MR3, 312702KMR3T, 312702MR3T, 630527MR1, 630527MR2, 1000003629, 312227750WMR, GON5407114, 217528MR4, 217528MR3, 812450MR2, 812842MR2, 913MMC750W, 337898MR2, 985NOMR4, 504CHMR3, 504VAMR3, BRIGHAM750WMR1, 617499MR3, 781SSHMR3, 413794MR3T, 240555AMR2, 202476MR5, 218249ARC3, 612467MR1, 763278ARC3T, 507372MRARC, 573884MR30, 417347MR2, 314MERCYOPMR1, 406751K3T3, 406751K3T2, 336832MR750, 402IMM3T, 201639MR3T, 973971MR3, 201445750W, 775882GBIMR, 702731MR750W, 518262MR750W, 718616MR3T, 718434MR, 718780MR3T, 716845MR, 631623MR750, 914734MR, 315UBJARCH, 718670MR3T, 516NS7113T, 212562MR1, COR568101, 212523MR3, WCIWMR1, WCIWMR2, 212477MR, RADNETMR1694, CHONYMR10, MSK53MR02, COR526967, 516798MR3T, 631726MR3T, 718226MR3T, 631638MR3T, 516231MR3T, 631376MR3T, 716845AMR, 330489MR3T, 513584MR4, 513584MR3, 216739MR3T, 614293MR9, 937641MR2, 937298MR2, 513636LMR1, 419557MR3T, 405271UMR2, 405752ICMR2, 918502MR2, 918502MR1, 484426MR, 484526MR3T, 412914MR, GON5421098, 814877MR750W, 814262MR3T, 215829MR3T, 412648MR2AR, 412623MR750W, 717764MR, 843777ARC3T, 605504MRARC, 605328MRARC, 605333MRARC, 901545MR3T, 901226MR3T, 9015163TARCH, 615342MR3T2, 615769MR3T, 325670HMR3T, 817472MCA3T, 5129013TO, 5129013T, 214559SRH3TMR, 214341PDDMR1, 903416TMMR2, 817329BSW3TMR, 956296MR750, 956389MR750, 713442KSMR3, 281NWARCHITECT, 713791VAMR3W, 281348MR2, 806UMCHWMR3T, 806775MR3T, 972665XBPMR2, 972708PDPMR1, 281274MR2, 830UMHARC3, 801LONEMR3, 801262MR4, 801373MR6, 801588MR3, 435251MR3, 757312MR3T, 703573ARC2, 703699MR1, 703573ARC6, 703698MR5, 703573ARC7, 703858MR2, 703737MR, 703982MR1, 757953SPMR, 8042893T, 425392PBMR, 425201750W, 360744HM750MR, 360696MR1, 920454MR1, 920568MR1, 608CHILDMR1, 608VAMR750W, 608265MR750W, 608263MR5W, 414955MR2, 414454MR1, 304293MR3T, MR8261AR, MR7862AR, MR6393AR, MR8406AR, MR9103AR, MR6042AR, MR1122AR, 83194303621, 83161978004, 83181649825, 83092403928, 83112923777, 83112923995, 83137149889, 834MR000003, 83178784816, 83164744322, 83193159006, 83104203907, 83187371397, MR52744011, 140024MR01, 130083MR05, 220826MR01, 220826MR02, 210013MR02, MRUA2200, MRUA1963, MRUA2152, MRUA1211, MRUA2006, MRUA1220, MRUA1042, MRUA0394A, MRUA2116, MRUA0976, BG4009MR02, 403777SIGNA3T, 780699MR3T, 905527MR1, 4799583MR11, E416249MR2, 905684MR3T, 506648MR4, 604582MR750, MR102094WH0, MRUA1656B, 082427110155, 082427110104, 082427110144, 082427040255, 082427220090, 082427220086, 082427110161, 082427110151, 082427140308, 082427100469, 082427090479, 082427030204, 082427100447, 082427140212, 082427100459, 082427090476, 082427130144, 082427230222, 082427160284, 082427040333, 082427120261, 082427180067, 082427150132, 082427090470, 082427090456, 082427010212, 082427010180, 082427160360, 082427160276, 082427230170, 082427120292, 082427120272, 082427250121, 082427030219, 082427140197, 082427030218, 082427100464, 082427140303, 082427100493, 082427170042, 082427170026, 082427150129, 082427120271, 082427280030, 082427180053, 082427060112, 082427090461, 082427190196, 082427190169, 082427190168, 082427150128, 082427150140, 082427160358, 082427160429, 082427160313, 082427160401, 082427160356, 082427180060, 082427180085, 082427180054, 082427170049, 082427070256, 082427070314, 082427070263, 082427010198, 082427010187, 082427090487, 082427090467, 082427040320, 082427090488, 082427090465, 082427090493, 082427090494, 082427090457, 082427090472, 082427090446, 082427090489, 082427090437, 082427090438, 082427090432, 082427090469, 082427210248, 082427210257, 082427210217, 082427210212, 082427120344, 082427120372, 082427120351, 082427120349, 082427120295, 082427120377, 082427120337, 082427200214, 082427200223, 082427030203, 082427030222, 082427030211, 082427030171, 082427030223, 082427040270, 082427140345, 082427070283, 082427080139, 082427090490, 082427190200, 082427130126, 082427130121, 082427160409, 082427140330, 082427200226, 082427290044, 082427040274, 082427200182, 082427200209, 082427090503, 082427110130, 082427070331, 082427090483, 082427080138, 082427160423, 082427100520, 082427120262, 082427200230, 082427120254, 082427250138, 082427310183, 082427210223, 082427210258, 082427160325, 082427160280, 082427160339, 082427160354, 082427070245, 082427210233, 082427090390, 082427090406, 082427120284, 082427130129, 082427060089, 082427060120, 082427060115, 082427060125, 082427060122, 082427300031, 082427140340, 082427160355, 082427100518, 082427130176, 082427100486, 082427100480, 082427100487, 082427100491, 082427130125, 082427310170, 082427080144, 082427080145, 082427310150, 082427080127, 082427080147, 082427230241, 082427050054, 082427270086, 082427270078, 082427250098, 082427250136, 082427250107, 082427250106, 082427140337, 082427140215, 082427130187, 082427130188, 082427130189, 082427130190, 082427130191, 082427130134, 082427250118, 082427250132, 082427040302, 082427040279, 082427040329, 082427020109, 082427020129, 082427020126, 082427020112, 082427020107, 082427230212, 082427230197, 082427230180, 082427230184, 082427230158, 082427230259, 082427230166, 082427230236, 082427230220, 082427050063, 082427110166, 082427110160, 082427100496, 082427100512, 082427100499, 082427100409, 082427100442, 082427100492, 082427100463, 082427100504, 082427100451, 082427100484, 082427100497, 082427100431, 082427100521, 082427100433, 082427100482, 082427160396, 082427160405, 082427160408, 082427160407, 082427160390, 082427160326, 082427160300, 082427160283, 082427160348, 082427160427, 082427160391, 082427160402, 082427160403, 082427160268, 082427160393, 082427180069, 082427030207, 082427120303, 082427120287, 082427120276, 082427120364, 082427120259, 082427120376, 082427120380, 082427120323, 082427120357, 082427120353, 082427120302, 082427120277, 082427120360, 082427120375, 082427120269, 082427120273, 082427120350, 082427200210, 082427200233, 082427200224, 082427200215, 082427200207, 082427070351, 082427070280, 082427070349, 082427070358, 082427070322, 082427070357, 082427070261, 082427090453, 082427090464, 082427090414, 082427090426, 082427090491, 082427090477, 082427090445, 082427090475, 082427090481, 082427090471, 082427140250, 082427140275, 082427140346, 082427140310, 082427140317, 082427140200, 082427140240, 082427140210, 082427170039, 082427210241, 082427210230, 082427210228, 082427210266, 082427210250, 082427190185, 082427190195, 082427190174, 082427290068, 082427150127, 082427150120, 082427150131, 082427150130, 082427240122, 082427030208, 082427030225, 082427030230, 082427220122, 082427220097, 082427220121, 082427220118, 082427310163, 082427310134, 082427310165, 082427310187, 082427310172, 082427310152, 082427010214, CY1028MR03, CS1006MR06, DK1547MR01, DK1547MR02, DK1549MR01, M4409455, 6786391, A1765918, M4018549, M4216469, M4017073, C21952103, M365865301, M4191127, M54807105, M1248634, M4040093, M41980120, M414406706, HC4929MR02, 360070MR01, PKOB02MR07, 624751MR01, H1039MR36, H1943MR23, 0828270058, HU1766MR01, 083027289269620, 083027008557723, 083027003625722, 083027001558421, 083027009590421, 083027006972719, 083027240825123, 083027241749522, 083027826696820, 083027286277319, 083027285275919, 083027204674620, 083027201983323, 083027280081224, 083027603507818, 083027043738521, 083027048505719, 083027805213421, 083027802798022, 083027009451123, 083027600149523, 7982MR0043, 7982MR0068, 7982MR0069, 7982MR0006, IE1111MR04, IE1038MR02, GON5446687, C5343136, A5105745, EM0256, EM0602, EM0601, EM0515, EM0513, MR00033, EM0509, EM0517, EM0923, EM0608, EM0606, EM0518, EM0929, MR00040, EM0919, EM0510, EM0600, EM0920, EM0615, EM0508, EM0317, EM0912, MR00006, EM0285, MR00136, MR00103, EM0607, MR00015, EM0504, EM0219, EM0928, EM0507, EM0512, EM0913, MR00071, EM0931, EM0511, MR00141, EM0906, MR00168, MR00169, EM0501, EM0506, MR00104, MR00185, EM0609, EM0514, EM0400, MR00021, EM0614, MR00124, EM0500, MR00077, EM0503, EM0245, EM0914, EM0502, MR00027, EM0908, EM0605, EM0611, EM0303, MR00228, EM0603, EM0203, EM0909, KA3300MR02, KA2801MR01, KA1139MR01, 0850270698, 0850270573, 0850270590, 0850270577, 0850270652, 0850270591, 0850270612, 0850270609, 0850270606, 0850270509, 0850270517, 0850270584, 0850270646, 0850270574, 0850270540, 0850270553, 0850270386, 0850270546, 0850270567, 0850270566, 0850270570, 0850270622, 0850270504, 0850270720, 0850270721, KW1010MR01, KW1013MR10, KW1013MR11, KW1100MR02, KW1008MR04, KW1008MR08, KW1011MR03, KW1005MR04, MR52661451, MR52661754, KW1155MR01, LV4001MR03, LB1160MR02, LB1001MR03, MRUA2042, MRUA2064, MRUA2408, 0920279031, 85110163303, 859MR000014, 85092252519, NO1012MR02, OM1007MR01, MRUA2219, MR8146PA, MRUA1416, MRUA2271, MRUA1314, MRUA1498, 1557MR0049, PL1398MR01, PL1111MR01, P00434MR01, 600092MR04, 600062MR01, PL1600MR01, PPS51801, PPS51802, PPS79500, PPS58406, PPR51811, PER19029, PPR96115, MRUA2257, QA1151MR02, MR50777961, MR53186271, RO1093MR02, RO1574MR01, RO1059MR04, RO1095MR02, RO1416MR02, RU6340MR03, RU1127MR04, RU9594MR01, RF3138MR01, RF1908MR03, RU1838MR04, RU7021MR01, RU1899MR01, RU2500MR02, RU2520MR01, RU9544MR01, RU1785MR02, RU3104MR02, RF0080MR01, RU1143MR03, RU1934MR01, RF3580MR01, SA1220MR02, SA1114MR02, SA5000MR06, SA5003MR03, SA1209MR02, SA1058MR05, 6073MR0052, 6073MR0020, ME645990, ME2083107, NPV64200, FEG88320, FEC800347, DE492A99, DED647165, DE6588189, DE2032127, DE5284117, DE528499, DPN26332, FE4438133, CEZ01560, MEX689444, DPN886102, NPD00400, YE645884, FP167513, NE419195, NEV439249, NPV64102, NPV64100, A004MR05, O009MR03, E001MR04, M001MR02, M004MR01, T002MR04, T002MR01, A020MR05, N002MR03, 850020MR02, 273354MR01, 529150MR01, 0850020MR02, 0853270220, 0853270201, 0853270218, 0853270214, 0853270192, 0853270223, 0853270202, 0853270212, 1573MR0042, 1573MR0024, 01002MRS04, 31020MRS01, 34492MRS01, 34418MRS01, 06051MRS02, 77624MRS06, 10044MRS05, 00132MRS01, 11187MRS01, 00023MRS01, 00020MRS04, MRUA0353, UZ1307MR01, 5973MR0074, 5973MR0056, 678342MR, 082427240126, 082427130197, 082427150141, 082427200219.

Quantity Affected: 834 units

Reason for Recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-06-14

Company