SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Mag... — FDA record Z-2470-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 14, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
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 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.
Classification
Class II
Recalling firm
GE Medical Systems, LLC
Quantity
1528 units
Agency-reported status
Ongoing
Source record identifier
Z-2470-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitySystem ID: 907373VMR, 256SPMR2, 870642MR, 5340995MR11, KRMCMR2, SMSCIA2, 714229MR2, SHIMR02637, 310358VMR, RADNETMR664, 559447MRVOYA3, 559447MRVOYA2, 559447MRVOYA1, INSIGHTMR1397, 626359VMR4, INSIGHTMR1371, ALLIANCEVOYA04, 707431MR, 323294VMR, 310823VMR, SHIMR02636, 818496HCMR1, 209SUTBMR, SHIMR02625, SHIMR02617, 530OROMMR, SHIMR02645, INSIGHTMR1385, INSIGHTMR1378, SHIMR02647, 13412, SHIMR02648, SHIMR02635, SHIMR02654, RADNETMR648, SHIMR02639, ALLIANCEVOYA11, INSIGHTMR1376, SHIMR02650, SHIMR02638, SHIMR02624, 818708MR2, 707462VOYMR, 661HMVMR1, 760247VMR, SHIMR02653, 303750MR, 307630MR2, 719394MR, 970242VAMR, 3036140MR, 720513MR, 970879VMR, 860289VOYAGER, 860659MRVOYAGER, 203453VOYAGER, 860347VOYAGER, 203834VOYAGER, 302655MR1, 561996MR1, 813315MR, 352597MR1, ALLIANCEVOYA01, 305445MR1, 904CSMR, 904627MR3, SHIMR02652, 321CLMRVOY, 305229MR1, 239NHVOY, 352ADVMR, 352867MR2, 941MPGPGVOY, 813655MR, 813874MR1, 941VOYMR, 850325MR1, 850877MR1, 229758MRI, 770539MR, MSF138-1-6XIAHPU7, 478745VMR, 229329MRI, SMSVIT7, SMSSVM8, SMSZOE3, SMSKIT1, SMSSVM1, SMSMAG1, SMSCAM2, SMSAMP1, SMSOMR1, 712737MRVOY, SMSWES4, 319352MR, SMSOAK2, 208735VOYMR, SMSCIA1, SHIMR2667, 618GOSHENMR, 847931MR, DSSMR5, SMSCAM1, 1000003628, 217QMGVOYAGER, SMSOMR5, 847252MRI, SMGMR59, DMSMR166, SMSZAG1, 812348MR2, 317415VOY, 574537MR, 574647VOYAGER, 574271MR, 812663MR2, 317899MR, 812283MR, SMSOMR2, SMSSVM4, SMSSVM3, 316613MR, 606833MRW2, DSSMR6, 606598MR2, 985ONCMR2, 4600722-MSF116-1-1-1, 985FWMR, SMGMR44, 337593VOYAGER1, 337470MR1, 318251GCVOYAGER, 978922MR, NBHMOBILEMR2, 617789MR, 508548MR1, 508825MR1, 781952MR, RADNETMR1712, RADNETMR1701, 301618MR1, 269979VOY, 248VOY, SJMOBILE, ALLIANCEVOYA10, 586263VOYA1, 248553VOYAGER, 810732VOYAGER, 906483VOYA, ALLIANCEVOYA03, ALLIANCEVOYA02, 269342VOY, 517VOY2, RMIMOBILEMR, ALLIANCEVOYA06, ALLIANCEVOYA08, 989583VOYMOB, ALLIANCEVOYA09, 952738MR1, SMSVIT1, 507537MRVOY, 612RICMR, 507825MRVOY, 320255VOY, 651747VOY1, WC231MR, SMSVIA1, SMSSVM2, 417891MR1, 601936VMR, 662377VOYMR1, 601883VMR, 406237TMR, 406587BOMR, 406455MR2, 406445CMR, 406449BMR1, 406751MMR, BPMOBILEMR12, BPMOBILEMR11, 828250VOYAGERMR, 828213MHMR, 4975485MR11, 704820VOYA, 704323MOB1, 704831CNMR2, MQ29NORFOLK, 704697VOYA, TRANSTATEMR1, 704783VOY, 980212MR, 704834VOY, 828681AHMR, 704895VOY, 980993VOYA, 252OBHMR, ALLIANCEVOYA05, 828766BRMR, 704CISMOB3, 910CRVOY, 701444MR, SMSWAY1, SMSSVM5, SMSOAK3, SMSKIT2, 402336VMR, MOB14GEMR, RADNETMR1693, SHIMR02618, ATLHLTHCLK, 732497MRVOY, 609597MRVOY, 973370MR, 732988MRVOY, 201261MR, 973837MR, LARCHVOYAGER, PMIM122MR, 775827NRHPMR, 518262VOYAGER, 518438MR2, 716250MR, ALLIANCEVOYA07, 718613MR, 718963MR, 716204VMR1, 716250VMR1, 585NOYESMR, 516GCVOY, 607535MR, 716217MR, 607337MR, 631758MR, 607865MR, 585716JONESMR, 631998MR, 914962MRI, 330AULTMR1, 330AULTMR1B, 330MMCM1, 724029MR1, 330AULTMR1A, 513793MR, 937236MR, 330AULTMR1D, MHKMMR1, 513424KHMR, 724029MR2, 740991MRW, WCOHC3, MHSPRGEMR1, 419933MR, 405224GMR, 580354MVMR, 405230MR, SMGMR46, 405749OSMR, SMSSVM6, 405273PMR, 405743MR, 918523MR3, 918940MR1, 405350MR, 541383MR, 541472VMR, 610402MR, 610317MR1, 717761MR3, 814624MR, 484498MR, 484224MR, 835215MR, SHIMR02646, 215707VOYAGER, 570621MR, SMGMR56, 570307MR1, 717765MR, 401793MR, 803936LMCMR4, 864229MRI, 843716MRV, 843236CFVOY, 803992VOY, 803936LMCMR1, 605217MRVOY, 605598MRVOY, SMSOAK1, 423697MR2, 423697MR1, 615WBJMR1, 615986HVPR, 865584MR2, 901516VOY, 806212VMR30, 817358HCABMR1, 713314MHOPM, 817293HMR1, 469221ADHMR1, 817294TSWMR1, 713451VOY1, 281955MR1, 713778MR1, 832658MHMR1, 817498TSHMR1, SMSMIX1, 817453EMMR1, 469846TSMMR1, 713929MR2, 281412MR1, 972712TINDMR1, 214214ABSMR1, 409729DHCMR1W, 972744TSRMR, 281341OBMR1, 972520TRSMR1, 210PINMRV, RADNETMR676, 210MSIPCV1, 210MSIPCV2, 210OICRV, 325574MRV, 713512MR1, 801377MR7, SMSUTA1, 801TANMR1, 801773MR2, 801SANPETEMR, 435EUSPMR, 435251VOY, 757312MRVOY, 757873MR, 804SPMR, 757707MR, INSIGHTMR1387, 253944SFMR, 206223VMR2, 206223VMR1, 425800MR, SMSVIT3, 920965MR1, 715330MR1, SMSWBI1, SMSWBI2, SMSVIT6, 414384VAMR1, SMSVIT2, SMSWES1, SHIMR02649, SMSWES3, SMSVIT8, SHIMR02642, 307630MR, 307755VMR, DZ2496MR01, DZ1820MR02, DZ1339MR05, DZ1090MR02, MR3755AR, MR6114AR, MR1836AR, MR2738AR, MR1518AR, 83169743687, 832MR000045, 832MR000028, 832MR000037, 832MR000047, 832MR000009, 83178031584, 834MR000034, 834MR000048, 834MR000036, 834MR000004, 833MR000018, 833MR000026, 833MR000007, 833MR000049, 833MR000022, AP6264MR02, MRPM0410, MR51339231, BY4120MR01, BY4075MR01, MRPM1143, MRRD0499, MR51028591, MRPM0249, MRPM1294, MRPM0790, MRRD0096, MRPM1193, MRPM0399, MRRD0259, MRRD0135, MRPM0592, MRRD0231, MRPM0566, MRPM0169A, MRRD0274, MRPM0972, MRRD0301, MRRD0224, MRPM0710, MRPM1256, MRPM1210, MRPM0656, MRRD0833, MRPM0452, MRRD0564, MRRD0364, MRRD0310, MRRD0773, MRRD0768, MRRD0492, MRRD0681, MRPM1212, MRRD0384, MRPM0803, MRRD0756, MRRD0202, MRRD0275, MRPM1186, MRRD0625, MRPM0955, MRPM1088, MRRD0932, MRPM1106, MRRD0129, MRRD0037, MRRD0368, MRRD0263, MRRD0105, MRPM0509, MRPM1257, MRRD0172, MRRD0712, MRRD0273, MRRD0079, MRPM1359, MRPM0920A, MRPM0878, MRPM0492, MRPM0304, MRRD0919, MRRD0719, MRRD0375, MRRD0244, MRRD0256, MRRD0206, MRRD0083, MRRD0038, MRRD0034, BG4786MR01, BG4853MR01, 6073MR0044, 6073MR0053, 6073MR0046, 780699MRV, 604675MOBMRV, 780612MRV, 403967MRV, 819563MR, 780679MRV, 450688MR1, 418653MR2, 306664MR1, 613283MR11, MR4243CL, 082427110138, 082427040313, 082427040321, 082427040326, 082427040331, 082427040241, 082427220142, 082427220135, 082427220107, 082427220088, 082427040315, 082427220110, 082427140307, 082427140202, 082427270088, 082427140267, 82427090504, 082427210249, 082427210240, 082427230255, 082427130112, 082427160336, 082427040266, 082427210203, 082427200193, 082427140209, 082427310146, 082427140217, 082427140213, 082427110111, 082427100391, 082427230189, 082427090376, 82427140341, 082427140301, 082427140251, 082427140214, 082427140191, 082427140198, 082427140231, 082427180057, 082427190181, 082427160297, 082427180056, 082427100414, 082427140227, 082427210225, 082427310144, 082427310139, 082427090387, 082427180058, 082427220129, 082427220098, 082427290060, 082427160322, 82427160428, 082427160330, 082427180059, 082427240116, 82427180087, 082427210220, 082427070232, 082427070252, 082427010190, 082427210260, 082427210216, 082427060110, 082427060101, 082427300034, 082427300037, 082427280032, 082427230203, 082427100510, 082427130127, 082427310138, 082427230208, 082427250102, 082427250135, 082427250120, 082427250134, 082427250130, 082427140289, 82427140339, 082427140321, 082427140211, 082427140335, 082427140234, 082427140258, 082427140218, 082427250128, 082427250113, 082427250126, 082427250127, 082427250119, 082427250114, 082427060109, 082427040310, 082427040327, 082427230162, 082427230210, 082427230215, 082427230217, 082427110109, 082427110121, 082427110114, 082427110116, 082427100475, 082427160404, 082427160309, 082427160296, 082427160304, 082427130139, 082427200169, 82427200236, 082427070323, 082427090418, 082427140300, 082427140336, 082427140338, 082427140322, 082427140248, 082427140278, 082427140265, 082427140257, 082427140193, 082427140343, 082427140273, 082427140249, 082427140216, 82427140331, 082427140288, 082427140241, 082427140252, 082427140194, 082427140235, 082427140195, 082427140222, 082427140259, 082427140206, 082427290045, 082427240092, 082427220089, 082427220095, MRPM0542, CS1027MR01, CS1090MR01, CS1328MR01, 600102MR01, DK1277MR02, DK1224MR01, DK1296MR02, DK1049MR01, DK1049MR02, MRPM0823, MRPM0361, MRRD0569, EG2982MR01, EG2707MR02, EG2707MR01, EG2676MR02, EG2131MR01, EG1795MR01, EG2939MR01, EG1525MR03, EG2849MR01, EG2563MR01, EG1542MR02, FI1012MR09, FI1012MR08, FI1015MR06, FI1530MR01, FI1003MR02, 9600192, X122205816, X151407614, 9524602, M4135328, X167162413, X240779701, 6249781, X628532201, MR52652781, GP1046MR03, 8953473, M4164357, M359673903, X868131021, 9974431, X706835020, M196514409, X669977019, X6002825, 9850617, 6211004, 8310782, 8880014, 8890678, M683032102, 8903130, 7296684, 7296685, 7310155, 9447001, X767340201, MR52305481, 8228707, 9721386, 8953472, 9672286, M511204701, M4438415, 6576447, M1425522, X102860309, 10025906, RE1197MR01, M5483014, X4184401, X185801212, 7143819, 8738801, M8321417, A5485280, M4187731, 8302064, 8912544, M429705301, X197096001, 8183586, 6825992, M2437608, A6023427, X255501005, X179963601, M4644049, 10005736, 8953464, 8363379, MR49413131, 6954494, 7023729, M160034205, 8953471, 8886546, 7960964, 8085680, M176430619, A9502030, M2863017, 7277820, 9495994, M2748230, 7448419, 7448420, X178710404, 8363378, 8270491, 8953465, 7951256, A4463352, F1669607, M682846501, 8089972, M477182002, 8106170, 6860447, 6260041, M1460214, M2850021, MR52650261, 8953467, 8953470, 7919523, MR52297861, M215631209, M386271503, X751964012, M2718174, M2718171, M2875118, M4433018, X4211069, 8532166, 7151482, 7034275, 6529145, M2228049, M2950014, 10047217, 7313350, X247551505, M136684818, B75162216, 8288087, M4216045, M1279753, 7861296, 7313558, X738353902, 8558934, GE1201MR01, PC1501MR02, 419729MR01, PC0075MR05, 113656MR01, 744459MR01, 221780MR04, CC0820MR13, 125528MR04, PC0233MR03, HC0114MR01, PC7343MR02, 160234MR02, 123701MR03, 477494MR01, PC0573MR04, PC2007MR03, TP0012MR02, 654076MR03, P00042MR03, HC1275MR01, 123740MR02, 852016MR01, 631515MR01, PC1961MR04, PC1961MR03, HC2862MR01, PC3817MR03, PC0304MR01, 118404MR02, 364839MR01, 477085MR01, HC3068MR02, 392574MR02, 125390MR02, PVIL01MR04, TP5555MR02, TP0575MR01, PC7590MR02, 168650MR01, 505458MR01, H44438MR03, H13491MR02, H10632MR17, H4478MR13, H7274MR01, H1066MR41, H1266MR13, H44439MR08, H10391MR18, H4443MR20, H5350MR14, H4145MR15, H47771MR19, H5049MR10, MRPM0705, 828270081, 0828270074, 0828270078, 0828270075, 0828270071, 0828270070, 0828270068, 0828270067, 0828270060, 828270076, 0828270066, 0828270061, 0828270057, 0828270054, HU1506MR01, HU1635MR01, HU1038MR04, HU1083MR02, HU1053MR01, HU1767MR01, HU1137MR01, HU1695MR01, 083027200941117, 083027809718817, 083027601763217, 7982MR0034, 7982MR0023, 7982MR0003, 7982MR0047, 7982MR0083, IR1288MR03, IR2616MR01, MR52387371, IQ1916MR01, IE1100MR03, IE1303MR01, IE1332MR01, IE1236MR01, IE1219MR01, IE1075MR03, IE1335MR01, 9610083, IE1334MRM1, IE1297MR01, 9877136, IL1062MR06, B5381867, A5714636, 9590090, A5360497, B5809217, 9584561, A141038605, B46832502, A171995615, K5345906, A5912924, A5170311, A5679107, A126322025, A468325104, 9065494, A104057306, A5810841, A5396913, A5141238, A223414521, B5123311, B5801754, A236501201, A5698025, A5158838, A5158841, A51149133, A208415217, A5379636, A5820187, A5820848, B5196801, A255888102, A5696703, 9553469, A5124405, A5331712, 9672284, A5229917, 9943704, A5769217, 9309518, A5196829, 9672288, A5226506, A51529240, A51529242, A228557101, C5618322, A56183194, A34802404, A5730007, A665033304, A665033301, B257027604, A5267111, B5201212, A5389824, A5671803, A5739718, A5191301, A5408631, A6195610, 10050105, A99155716, A5985917, A5174278, A5721921, ZC0316, MR00039, MR00130, ZC0206, MR00066, MR00159, MR00116, MR00028, MR00211, MR00109, MR00032, ZC0317, MR00105, ZC0320, MR00167, ZC0101, ZC0203, MR00064, ZC0310, ZC0311, ZC0205, MR00243, MR00232, MR00010, MR00186, ZC0210, ZC0107, MR00175, ZC0204, MR00129, ZC0106, MR00114, MR00188, MR00190, MR00007, MR00154, ZC0209, MR00100, MR00110, MR00094, MR00049, MR00084, ZC0104, MR00022, MR00083, ZC0201, ZC0105, ZC0103, MR00096, ZC0321, MR00102, ZC0102, ZC0202, MR00119, MR00150, JO4094MR01, JO4167MR01, JO4161MR01, KA2953MR01, 0850270741, 0850270774, 850270803, KW1198MR01, KW1144MR01, KW1189MR01, KW1002MR02, KW1146MR01, MR51916571, MR49467811, LV4058MR02, LV4002MR02, LV4038MR02, LB1519MR01, LB1493MR01, MR52924261, LB1537MR01, LB1039MR01, MR49219531, LT4110MR01, LT4001MR01, LT4006MR03, MR52002551, LT4122MR01, MC4035MR01, 1553MR0018, 1553MR0013, 1553MR0019, 1553MR0017, 1553MR0022, MRPM1060, MRPM0606, MRPM0394, MRPM1045, MRPM1066, MRPM0756, MRPM0660, MRPM0548A, MRPM0454, MRRD0406, MRRD0582, MA1421MR02, MAMR49502761, MR49502761, MR52293801, MA1884MR01, MR51168921, MA1690MR01, MA1002MR03, ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date
Aug 14, 2024
Recall initiation date
Jun 14, 2024
Center classification date
Aug 2, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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