Recall archive / FDA device enforcement
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance I... — FDA record Z-2473-2024
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 Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, 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
- 2528 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2473-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | System ID: K2308, SHIMR02644, 415723SHMR6, 951682MR, 619291MR1, 2533, 303355MR, 305682MR1, 727869MR, 352344MR2, 407PIMRKCH, 630332MR, 316689MR, 508746JMR2, 406863WMR, 445MR2, 718567MR, 718250MR, 716839MR1, MSF094-1-6UQ9H2TJ, 412784MR1, 830643MMR2, 540776MR2, 360582450WPA, MSF094-1-6VI2CR9B, 630843OSCMR, AL4093MR01, DZ1638MR02, DZ2685MR01, DZ1930MR01, DZ4483MR01, DZ2684MR01, DZ2183MR01, DZ3053MR01, DZ1947MR01, DZ1305MR01, DZ1863MR01, DZ1035MR03, DZ1004MR03, DZ1004MR02, DZ4258MR01, DZ1601MR01, DZ1146MR01, DZ1504MR01, DZ1269MR01, DZ4165MR01, DZ3484MR01, DZ1339MR04, DZ1070MR01, DZ4047MR01, DZ2417MR01, DZ2418MR01, DZ3741MR01, DZ4609MR01, DZ2090MR01, DZ2785MR01, DZ2552MR01, DZ3365MR01, DZ4149MR01, DZ3445MR01, DZ1149MR02, DZ1337MR01, DZ2622MR01, DZ1268MR01, DZ3165MR01, DZ4313MR01, DZ1406MR03, DZ1771MR01, DZ1406MR02, DZ2092MR01, DZ1027MR01, DZ2014MR01, DZ1060MR05, DZ1297MR01, DZ2764MR01, DZ4227MR01, DZ2773MR01, DZ3805MR01, DZ2351MR01, DZ1475MR01, DZ1908MR01, DZ2361MR01, DZ1856MR02, DZ4929MR01, DZ3953MR01, DZ3078MR01, DZ2995MR01, DZ1255MR01, DZ4380MR01, DZ3087MR01, DZ1466MR01, MR3766AR, MR1946AR, MR9321AR, MR3338AR, 2722SIGNA15, MR3867AR, MR2812AR, MR6472AR, MR1196AR, MR8785AR, MR4330AR, MR8126AR, MR3498AR, MR8882AR, MR5700AR, MR6883AR, MR6459AR, MR7206AR, MR6816AR, MR8830AR, 4365SIGNA15, MR6899AR, MR9700AR, 264EXCHDE, MR3403AR, MR8229AR, MR2932AR, MR5239AR, MR3718AR, MR5150AR, MR7906AR, MR6855AR, MR8433AR, MR8920AR, MRR9946, MR9679AR, MR1936AR, MR2346AR, 4127SIGNA15, MR5043AR, MR8907AR, 3722SIG15T, MR7077AR, MR8570AR, MR2042AR, MR1437AR, MR1245AR, MR7856AR, MR2433AR, MR1720AR, MR5444AR, MR5790AR, 0910272080, 0910272089, 0910272087, 83151656091, 83193107602, 83147183761, 83207359389, 833MR000001, 83140192745A, 83215453018, 83151589682, 83200805122, 83164742085, 83212927900, 083027606532922, 083027609288917, 083027605498616, 083027608479920, 083027600426022, 083027606875420, 083027607691119, 083027604109319, 083027601632818, 083027600426222, 083027600874617, 083027606911319, 083027600486516, 083027606521417, 083027601703117, 083027607417021, MR52743961, 210110MR01, 083027608604518, MRRD0622, MR1726BO, MR7065BO, 2560124, BA4147MR01, MR51360451, MRR9040, MRR7716, 2849423, MRR10602, 1175978, MRRD0670, MRR9917, MRR8311, MRRD0764, MRR10597, MRR11632, MRR11499, MRRD0889, MRRD0859, MRR7919, MRRD1291, MRRD1157, MRRD0392, 2651970, MRR11526, MRRD1085, MRRD0909, MRR10914, 2705171, MRR11466, MRR11251, MRRD0632, MRRD0568, MRRD0436, MRR11576, MRR4548A, MRR11178, MRR10328, MRR10064, 1337081, 2839886, 74954, 2626380, 2761824, MRRD1232, 1347499, MRRD0634, MRR11488, MRR11621, MRR11456, MRRD0466, MRR10927, MRRD0412, MRR11001, 2599138, MRR11619, MRRD1004, MRRD0679, MRR11293, MRRD0437, 1192292, MRR11186, MRR11404, MRRD0673, MRRD0352, MRRD0314, MRRD1180, MRRD1159, MRR10160, MRRD0401, MRRD1400, MRRD0393, 1200823, 60357, MRRD1254, 34574, MRRD0538, 2707330, MRRD0927, MRR11566, MRR8015, MRRD0595, MRRD0470, MRR8517, 2682131, MRR11494, MRR11297, MRR11108, MRRD0924, MRR10744, MRR9306, MRRD0616, MRR11626, MRR11375, MRR1183, MRR11031, MRR11087, MRR10855, MRR1560SX2, MRRD1324, MR1543SX8, MRR11547, MRR10840, MRR11391, MRR10939, MRRD1002, MRRD1122, MRRD0813, MRR11657, MRRD0988, MRR11177, 33262, MRR9279, MRRD0579, MRR11646, MRR11618, MRR11636, MRR11579, MRR11577, MRR11562, MRR11536, MRR11088, MRR10899, MRR10997, MRR11000, 1292548, 2705318, 1202470, 2613126, 1167491, 1196362, 1200954, 1184373, MR1355680, MRR11187, MRR8992, 2807598, MRR11614, 2831309, MRR10084, MRR8562, MRRD0958, MRR11647, MRRD0865, MRRD1383, MRRD0877, MRR11630, MRR3140, MRR6664, MRR8267, MRRD1081, 2713328, MRR11610, MRR10845, 2728519, MRR11653, MRRD0419, 2776720, 2668464, MR255906MR0, 1238483, MRRD0905, MRRD1181, MRRD0914, MRR11372, MRRD1020, MRR10964, MRR10813, MRYR2150, MRR10826, MRRD0952, MRRD1050, MRR8789, MRR11471, 2742381, MRR9929, 2713415, MRR8057A, MRR10274, 1344119, MRR11223, MRR11081, 2535122, MRR11038, MRR8310, 2708848, MRRD1037, 4737487MR11, MRR11640, MRR11555, MRR11382, MRR11358, MRR11188, MRR10995, MRR8405, MRR8460, 2831204, 26290-1, 2730904, 1202525, 1202522, 1202515, MRR8605, 2626827, MRRD0480, 47924-1, MRRD0828, MRRD0411, BR93131XXX, BG4600MR01, BG4612MR01, MR51201071, MR52096141, 250782MR, MRR6466, MRR1120, MRR8034, MRR1946, CUCMR1, MR4038CL, MRRD0718, MR2527CL, MRR8837, MRR2854, MRR10957, MR1914CL, MRRD0680, MRR4116, MRR1134, MR5061CL, MEDSMR1, MRR8531, MRRD0997, MR9406CL, MR8714CL, HBLUCOMR01, MRR5840, MR7894CL, MRR2425, 082427040285, 082427040212, 082427040225, 082427040216, 082427040203, 082427220123, 082427220082, 082427220064, 082427130173, 082427130093, 082427100312, 082427060090, 082427270068, 082427160302, 082427160292, 082427040223, 082427040237, 082427040231, 082427230156, 082427090448, 082427090400, 082427200216, 082427010155, 082427090373, 082427090380, 082427100288, 082427090337, 082427160241, 082427090323, 082427190147, 082427160375, 082427230154, 082427120225, 082427080107, 082427080078, 082427250080, 082427140145, 082427030173, 082427030163, 082427160227, 082427090362, 082427090358, 082427100296, 082427070233, 082427070182, 082427250082, 082427140186, 082427280019, 082427090384, 082427240095, 082427220077, 082427220071, 082427030180, 082427190150, 082427100407, 082427090403, 082427290030, 082427160235, 082427160319, 082427160310, 082427160318, 082427160256, 082427160362, 082427160238, 082427240074, 082427070215, 082427010134, 082427010129, 082427090401, 082427090334, 082427090305, 082427090328, 082427090434, 082427090419, 082427090436, 082427090321, 082427090393, 082427090325, 082427090303, 082427090295, 082427210191, 082427210198, 082427190139, 082427120214, 082427120290, 082427110140, 082427200151, 082427200238, 082427200201, 082427020097, 082427020111, 082427060119, 082427060095, 082427190143, 082427160242, 082427100347, 082427100305, 082427100396, 082427100307, 082427100294, 082427100338, 082427130117, 082427080071, 082427310174, 082427230148, 082427230262, 082427230253, 082427230245, 082427270071, 082427270076, 082427250083, 082427250081, 082427250065, 082427250122, 082427250096, 082427250094, 082427250079, 082427250072, 082427140183, 082427140180, 082427140157, 082427160225, 082427250084, 082427060092, 082427060088, 082427040272, 082427040254, 082427040238, 082427230121, 082427230145, 082427300036, 082427100397, 082427100418, 082427100405, 082427080129, 082427160252, 082427160343, 082427160197, 082427160307, 082427160250, 082427270061, 082427120369, 082427120308, 082427120331, 082427120333, 082427120334, 082427120345, 082427120330, 082427120191, 082427120326, 082427200147, 082427070189, 082427070277, 082427070202, 082427070318, 082427090433, 082427090296, 082427140178, 082427140179, 082427140188, 082427140187, 082427290041, 082427290064, 082427240080, 082427240105, 082427240121, 082427030138, 082427030212, 082427220084, 082427220126, 082427220081, 082427220105, 082427310129, MRRD0996, MRR97761, MRR9674, MRR9230, MRRD0698, MRRD0619, MR5368CO, MR3630CO, MR4479CO, MRR10843, MRR9801, 2839703GOLD, 2672732SIGNA, 2697548EXCITE, 2670275HORIZON, 2624537EXCITE, 2605060SIGEXT, 2586967SIGNA, 2567464SIGNAMR, MRR9706, 2812553GOLD, MRRD1139, MRR10955, MRR10892, MRR9513, 2887023XT, 2874631HDE1, MRRD1317, MR4574CO, MRR10359, 2806308HD, MRR10144, 2778960SIGNA, MRRD1323A, 2824773LX, MR5440CO, MRR10073, MRRD1434, MR2048CO, 2566917SIG15T, MRR10762, MR1205CO, MR8006CO, MRRD1175, MR8073CO, MR2257CO, MRRD0572, 2883683SIGNA, CI1040MR01, CI1089MR01, HR4029MR01, DK1083MR05, DK1083MR03, MRRD1444, 2726108MRHD, MRRD1356, MRRD1260, MR2582DO, MR5218EC, MRR9885, 2932192EX2, EG2782MR01, EG2761MR01, EG1790MR02, EG2763MR01, EG2629MR01, EG2661MR01, EG1238MR02, EG2604MR01, EG1709MR01, EG1526MR04, EG1237MR01, EG1118MR01, EG2717MR01, EG2558MR02, EG2572MR01, EG1037MR03, EG1284MR02, EG2754MR01, EG3013MR01, EG2940MR01, EG2948MR01, EG5723US04, EG1005MR03, EG1246MR01, EG1053MR02, EG2713MR01, EG2595MR01, EG1543MR01, EG1121MR01, EG1505MR02, EG1522MR02, EG1998MR01, EG1054MR03, EG2579MR01, EG1826MR02, EG2557MR02, EG2650MR02, EG2570MR01, EG1929MR02, EG1277MR01, EG1196MR01, EG2641MR01, EG1245MR01, EG2920MR01, EG1525MR04, EG1126MR01, EG2601MR01, EG1008MR03, EG1042MR01, EG3010MR01, EG1783MR02, EG1990MR01, EG1279MR01, EG2581MR01, EG1743MR01, EG2266MR01, EG2716MR01, EG2556MR02, EG2633MR01, EG2663MR01, EG2582MR01, EG1112MR02, EG2594MR01, EG1043MR02, EG1804MR01, EG2569MR01, EG1744MR01, EE4026MR01, MR51028551, MR51796811, MR51028131, ET1021MR02, ET1021MR01, ET1296MR01, MR50061091, FI1502MR01, FI1345MR01, FI1064MR01, FI1041MR01, FI1021MR02, X121122503, M4161670, M2045019, X171897213, M359673901, M2321310, X706835017, M196514411, X669977018, M4400430, M2485631, M2271518, GF1007MR01, 7361387, X141549007, M189104208, X2881410, GON5412312, M6063014, M347028307, M2748747, X151054614, 7461157, X178185401, L2202007, MR54068981, MQ1038MR04, MQ1038MR03, 6529149, X306788201, M1265008, M1265006, X472561001, M2618005, X756087033, M4183856, A128275409, X128275412, X185801209, M24313809, M222271601, 8264764, M6414733, M6414732, A1279217, M9886878, X116370513, 9826031, M2269855, 6968494, M2844564, M2533237, M1245737, M4503514, X288892404, M4152262, 08830630, 08486357, M200598212, X86070201, M414406701, 6098456, A1588543, X216471209, 8224770, X304369405, X304369401, X225779101, M190091214, RE1045MR02, 8526228, X970562025, 6242121, X2266305, X226587717, M477182001, GP1022MR02, 07143820, M4204524, 7141789, 07816651, X751968037, M2848451, M245413303, X533536502, B75162215, 7210650, M4216043, M6015639, M4497429, HAMB02MR01, 389077MR01, PA0148MR01, 396399MR02, 712330MR01, PC0075MR03, PX4178MR02, PX4178MR01, PC6132MR03, PC1351MR01, 393115MR01, 233637MR01, 160234MR01, PC1401MR01, 561545MR01, PC0702MR01, PNUE07MR01, 543871MR01, 560776MR02, 560776MR01, PC0573MR02, PC2007MR01, CO3030MR02, PC8740MR01, 519759MR01, 527556MR02, 505560MR01, TP0010MR01, PC1455MR01, PC3885MR01, HC5284MR03, PC0396MR10, 123702MR03, PC0396MR04, 505168MR01, 410725MR01, CC5340MR02, 265361MR03, PC5995MR01, PC0815MR03, PC4537MR02, PNUE06MR01, HC1711MR01, 420127MR02, PNUE04MR01, PC0125MR03, 126548MR01, PC4036MR01, 631485MR01, 487692MR01, HC9027MR02, PC0345MR02, 360937MR01, HC0628MR01, 220112MR01, PC3847MR01, TP0011MR01, 124454MR01, TP0008MR02, TP0009MR01, 145599MR01, 505562MR01, 468993MR01, PC3827MR03, HC6474MR02, H44436MR04, H41222MR02, H7024MR06, H1339MR03, H55722MR02, H17659MR1, H4562MR01, H42261MR01, H3044MR01, H17660MR3, H44432MR01, H6933MR01, H1787MR11, H1892MR12, H17666MR1, H44435MR03, H10634MR08, H4352MR05, H41223MR02, H4676MR03, H10651MR06, H4767MR02, H4079MR03, H3943MR01, H10635MR09, H17646MR04, H17655MR01, H7247MR01, H4262MR05, H2126MR16, H1926MR05, H1141MR24, H5531MR01, MRRD0868, MRR10967, 24527633818MRI, 24501195MR-1, 0828270079, 0828270077, 0828270069, 0828270048IB01, 0828270030IB01, 0828270050, 0828270049, 0828270045, 0828270020IB02, HU1749MR01, HU1243MR02, HU1099MR02, HU1842MR01, HU1583MR01, HU1897MR01, HU1672MR01, HU1744MR01, HU1641MR01, HU1835MR01, HU1831MR01, HR4269MR01, HU1886MR01, 083027846253819, 083027841277017, R83027844086323, 083027842020719, 083027846984620, 083027848070318, 083027846535119, R83027843424622, 083027840081018, 083027848396318, 083027849417418, 083027840855323, 083027848785516, 083027600909023, 083027603366516, 083027607457016, 083027104892617, R83027103776223, 083027100019412, 083027103536122, 083027102603721, 083027108786816, 083027102101447, 083027100049812, 083027109470819, 083027066508118, 083027820010312, 083027000949218, 083027006503017, 083027003155616, 083027009317018, 083027006678722, 083027005494719, 083027606048519, 083027001571315, 083027008063017, 083027242173520, 083027243088818, 083027246179917, 083027243411217, 083027245187515, 083027241541616, 083027247170216, R83027243887423, 083027242389615, 083027240009214, 083027061463720, 083027066503518, R83027064146723, 083027806275019, 083027006661822, R83027104625724, R83027824110923, 083027822898921, 083027826697920, 083027827198515, 083027820038511, 083027826405518, 083027820801321, 083027826430817, 083027824626519, 0... |
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.