SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    System ID: 479397NUTEX, 407PRMDMR, 828210VETMR, DZ3736MR01, DZ3048MR01, DZ3898MR01, DZ1033MR03, DZ2763MR01, DZ2416MR01, DZ1174MR01, DZ4681MR01, MR9988AR, MR4790AR, MR4652AR, MR2498AR, MR9874AR, MR9143AR, MRR10900, MR6013AR, MR1950AR, MR3050AR, MR8927AR, MR7221AR, MR9664AR, MR6931AR, MR3104AR, MR3642AR, AM1032MR01, 83194404670, 083027608484817, 083027603618122, 083027600102223, 083027600101523, 083027602480921, 083027601272821, 083027600102423, BA4188MR01, BW6016MR01, MRR5332, MRR4141, MRR6531A, MRRD0604, MRR2844, MRRD0991, MRR3439, MRR5861, MRRD1097, MRR5800, MRR3997, MRR4316, MRR1175, MRRD366, MRR10976, MRR049, MRR11573, MRR11608, MRR2667, MRR10693A, MRR11288, MRR7419, MRR5942, MRR7312, MRRD0685, MRRD0627, MRRD0381, MRR3619, MRRD0341, MRRD0494, MRR10881, MRRD0521, MRRD0671, MRR4146, MRR5666, MRR3673, MRR1940, MRR11258, MRRD1049, MRRD0476, MRR11477, MRRD0971, MRR3777, MRR7385, MRRD1008, MRR2924, MRR2459, MRRD1171, MRRD0840, MRR3579, MRR974, MRR1555, MRRD1027, MRRD0570, MRRD0751, MRRD1117, MRR6443, MRR1972, MRRD1376, MRRD1005, MRR11625, MRR11481, MRRD1149, MRR3633, MRR7215, MRRD0527, MRR5040, MRRD0738, MRR11243, MRRD0378, MRR1577, MRRD1091, MRR11242, MRR5941, MRRD0488, MRR5267, MRR11065A, MRR6333, MRRD1042, MRR11395, MRR10831, MRR135, MRR4005, MRRD0502, MRR5138, MRR3509, MRR142A, MRRD0356, MRR3558, MRR3433, MRR088, MRRD0518, MRR1333, MRR3652, MRRD1205, MRRD0469, MRRD0424, MRR276, MRYR2176, MRRD0545, MRRD0372, MRR11524, MRR5150, MRR1573, MRR2043, MRR11365, MRR5178, MRR11559, MRR11497, MRR6863, MRR11181, MRR2358, MRRD0587, MRR5082, MRRD1012, MRR192, MRR6655, MRR6554, MRR2760, MRRD0389, MRRD1032, MRR1024, MRR2476, MRR798, MRRD0659, MRR11057, MRR4972, MRR6939, MRR5747, MRRD1001, MRRD0577, MRRD0743, MRR2507, MRRD1164, MRR2226A, MRRD0598, MRRD0302, MRR11458, MRR425, MRR3730, MRRD1168, MRR493, MRRD1109, MRRD1062, MRRD0936, MRR1397, MRR4501, MRR2825, MRRD0430, MRRD0431, MRR11250, MRR10953, MRR10951, MRR10915, MRR2188, MRRD0567, MRR10671, MRRD0220, MRR11241, 6073MR0008, 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PC1077, MR00041, PC6287, PC1055, PC6219, PC6125, MR00111, PC6185, PC6170, PC1064, MR00191, PC1049, PC6233, PC1010, PC1053, PC1015, PC0818, PC1052, PC1037, PC1008, PC1068, MR00065, MR00073, PC6154, PC1002, MR00236, PC1061, PC6118, PC1100, PC6258, PC6129, PC6259, PC1041, PC6245, PC6276, PC6196, PC1009, PC1021, MR00187, MR00174, PC1031, PC6278, PC6169, PC1043, PC1048, PC6274, PC1038, JO4217MR01, JO4223MR01, JO4216MR01, JO4140MR01, JO4142MR01, JO4239MR01, JO4102MR01, KA3323MR01, KA3400MR01, KA3287MR01, KA1072MR01, KA3399MR01, KA3299MR01, KA2844MR01, KA3284MR01, KA2964MR01, KA3033MR01, KA1121MR01, KA3098MR01, KA2849MR01, KA3126MR01, KA2741MR01, KA2977MR01, KE6097MR01, 0850270568, 0850270499, 0850270678, 0850270749, 0850270736, 0850270716, 0850270660, 0850270649, 0850270618, 0850270589, 0850270476, 0850270494, 0850270779, 0850270642, 0850270596, 0850270563, 0850270692, 0850270507, 0850270697, 0850270669, 0850270665, 0850270625, 0850270569, 0850270628, 0850270493, 0850270479, 0850270474, 0850270760, 0850270767, 0850270644, 0850270620, 0850270545, 0850270501, 0850270666, 0850270696, 0850270630, 0850270637, 0850270593, 0850270588, 0850270536, 0850270496, 0850270770, 0850270765, 0850270744, 0850270738, 0850270748, 0850270682, 0850270647, 0850270619, 0850270607, 0850270576, 0850270549, 0850270534, 0850270506, 0850270495, 0850270712, 0850270701, 0850270694, 0850270560, 0850270531, 0850270532, 0850270751, 0850270726, 0850270667, 0850270600, 0850270761, 0850270564, 0850270508, 0850270518, 0850270472, 0850270769, 0850270745, 0850270634, 0850270617, 0850270768, 0850270782, 0850270790, 0850270785, 0850270766, 0850270746, 0850270763, 0850270750, 0850270757, 0850270743, 0850270727, 0850270691, 0850270711, 0850270670, 0850270663, 0850270653, 0850270643, 0850270651, 0850270594, 0850270559, 0850270510, 0850270511, 0850270480, 0850270704, 0850270679, 0850270759, 0850270557, 0850270680, KT1124MR01, LB1456MR01, LB1220MR01, LB1005MR01, LB1037MR02, LY1157MR01, 1553MR0069, 1553MR0005, 1553MR0014, MRR5629, MRRD1007, MRR7040, MRR4068, MRRD0654, MRR11209A, MRRD1183, MRR11495, MRR3789A, MRRD1142, MRR1004, MRR10780, MRR4983, MRR108, MRR3530, MRR985, MRR11628, MR006784TA3, MRG2KS17002, MRR050, MRRD0400, MRR6425, MRRD1108, MRG2KS17007, MRR2675, MRR3242, MRRD0370, MRCRE1800016TJ, MRG2KS17006, MRR8692, MRR3785, MRR2802, MRRD1331, MRR3970, MRRD0280, MRR3525, MMRR1726, MRR2632, MRRD0464, MRRD0348, MRRD1090, MRR4544A, MRR11225, MRRD0682, MRR7759, MRRD0986, MRR1026, MRRD0661, MRR2295, MRR4854, MRRD0703, MRRD0398, MRR11313, MRR11719, MRR318, MRR3171, MRR2208, MRR2938, MRCRE1800105TJ, MRRD0903, MRR1170, MRR2744, MRR5020, MRRD0949, MRR2814, MRYR2088, MRRD1043, MRR11272, MRR8159, MRRD0283, MRRD0985, MRR5373, MRR370A, MRR2860, MRRD1197, MRRD0638, MRR2508, MRR1182, MRRD1138, MRR4434, MRRD0340, MRR11043, MRRD1126, MRRD1204, MRR3419, MRR3182, MD1096MR01, 082427320004, ME3002MR02, MR50565031, MR50760571, MA1908MR01, MA1841MR01, MAMR50565031, MR51359651, MA1214MR01, MA1883MR01, MA1780MR01, MA1268MR01, MA1540MR01, MA1493MR01, MR50547781, MR52294081, MA1548MR01, MA1651MR01, MA1527MR01, MA1472MR01, MA1581MR01, MA1574MR01, MA1895MR01, MA1528MR01, MA1516MR01, MR52673071, MA1649MR01, MR52673261, MR49897611, MA1668MR01, 6073MR0039, 083027006963718, 083027001117523, 083027005964822, 083027000767723, 083027000768323, 083027006234424, 083027001417122, 083027006246519, 083027003379023, 083027002672317, MR52574901, NG1746MR01, NG1048MR01, NG1868MR01, NG1430MR01, NG1704MR01, NG1171MR01, NG1876MR01, NG1853MR01, NG1377MR01, NG1743MR01, 8607632, MR51274611, 8718381, NG1333MR01, NG1702MR01, NG1978MR01, NG1951MR01, NG1745MR01, NG1880MR01, NG1144MR01, 8807712, NG1991MR01, NG1958MR01, NG1796MR01, NG1843MR01, NG1434MR01, NG1042MR02, OM1087MR01, MR51128743, MR50241901, MR51992191, MR53130881, PA1099MR01, MRR5157, MR7765PY, MR2317PY, MR6843PE, MRRD1070, MRRD0731A, MR3773PE, MR1645PE, 1557MR0006, 1557MR0009, 1557MR0026, 1557MR0014, 1557MR0019, 1557MR0029, 1557MR0048, 1557MR0008, 1557MR0031, 1557MR0062, 1557MR0024, 1557MR0027, 1557MR0035, 1557MR0039, 1557MR0028, 1557MR0015, 1557MR0042, 1557MR0063, 1557MR0055, 1557MR0040, 1557MR0023, 1557MR0054, 1557MR0046, PL0320MR01, PL0620MR01, PL3500MR01, PL0467MR01, PL0068MR01, PL3886MR01, PL0064MR01, PL3544MR02, PL3697MR01, PL0588MR01, PL0130MR01, PL3548MR01, PL3625MR01, PL3623MR01, PL0250MR01, PL0439MR01, PL0003MR01, PL3696MR01, PL3595MR01, PL0636MR01, PL0065MR01, PL1778MR01, PL3885MR01, PL1840MR01, PL0286MR01, PL1063MR01, PL3794MR01, PL0083MR01, PL0281MR01, PL0657MR01, PL3810MR01, PPS32605, PPS16207, MR8084PR, MRR1448, MR4980PR, MRR6279, MRR2728, MRR3155, RO1523MR01, RO1424MR01, RO1588MR01, RO1311MR01, RO1511MR01, RO1118MR02, RO1236MR01, RO1629MR01, RO1530MR01, RO1459MR01, RO1506MR01, RO1508MR03, RO1508MR02, RO1114MR01, RU2283MR01, RU9636MR01, RU7742MR01, RU3152MR01, RF1194MR01, RU7746MR01, RU6350MR01, RU3137MR01, RU1228MR01, RU0002MR01, RF0314MR01, RU5488MR01, RU3022MR01, RU1826MR01, RU3232MR01, RU6265MR01, RU0164MR02, RU4468MR01, RU0003MR01, RU3158MR01, RF0211MR01, RU2235MR01, RU7612MR02, RU9105MR01, RU1242MR01, RF0062MR01, RU2711MR01, RU1757MR01, RU4355MR01, RU1117MR01, RU8271MR01, RU6890MR01, RU7310MR01, RU3639MR01, RU0731MR01, RF1053MR01, RF1203MR01, RU3192MR01, RU3315MR01, RU7447MR01, RF0196MR01, RU9155MR03, RF1075MR01, RU9320MR01, RU5475MR01, RU0441MR01, RU1339MR01, RU1140MR01, RF0771MR01, RF2928MR01, RU0476MR01, RU7579MR01, RU0658MR01, RU4670MR01, RU1820MR03, RF2395MR01, RU8782MR01, RU3930MR01, RU8778MR01, RU1266MR01, RU1810MR01, RU2010MR01, RF0328MR01, RU2445MR01, RU1030MR02, RU2047MR01, MR50188321, RW1049MR01, SA2677MR01, SA2712MR01, SA2425MR01, SA2846MR01, SA2859MR01, SA2760MR01, SA1231MR02, SA2468MR01, SA1043MR02, SA1064MR02, 6073MR0050, 6073MR0057, 6073MR0056, ZA3062MR01, ZA3061MR01, ZA2878MR01, ZA3263MR01, ZA1451MR01, ZA2669MR01, DPN85207, NPV62500, MPX51400, FPG86456, DPN29025, NPV60100, NPV58600, YP602101, CPZ13807, GPX37401, UE743A02, YP096106, FPG40900, DP596308, NPV74501, SZ0001MR01, 0853270163, 0853270229GS, 1573MR0071, 1573MR0074, 1573MR0025, 1573MR0044, 1573MR0029, 1573MR0046, 1573MR0016, 1573MR0035, 1573MR0018, 1573MR0037, 1573MR0038, 1573MR0021, 1573MR0008, 1573MR0052, 1573MR0020, 1573MR0003, 1573MR0040, MR9345TT, 01053MRS01, 01054MRS01, 04009MRS01, AE1630MR01, AE1557MR01, AE1149MR02, UZ3009MR01, UZ1099MR01, UZ1321MR01, MR51310811, UZ1018MR01, UZ1001MR04, UZ1353MR01, UZ1063MR01, UZ1320MR01, UZ1085MR01, MR51310631, MRR376, 5973MR0032, 5973MR0104, 5973MR0090, 5973MR0024, 5973MR0012, 5973MR0063, 5973MR0014, 5973MR0031, 5973MR0068, 5973MR0047, 5973MR0097, 9830MR0112, 5973MR0091, 5973MR0076, 5973MR0050, 5973MR0015, 5973MR0075, 5973MR0053, 5973MR0100, 9830MR0114, 5973MR0095, 5973MR0087, 5973MR0079, 5973MR0077, 5973MR0069, 5973MR0051, 5973MR0054, 5973MR0011, 5973MR0060, 5973MR0052, 5973MR0027, 5973MR0042, 5973MR0025, 5973MR0016, 5973MR0083, 5973MR0064, 5973MR0094, 5973MR0023, 5973MR0022, 5973MR0028, 5973MR0026, 5973MR0040, 5973MR0081, 5973MR0080, 5973MR0096, 5973MR0088, 5973MR0099, 5973MR0101, 5973MR0106, 5973MR0107, 5973MR0109, 5973MR0103, 5973MR0072, 5973MR0067, 5973MR0055, 9830MR0111, 9830MR0117, 5973MR0086, 5973MR0089, 9830MR0113, 5973MR0061
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Product Codes/Lot Numbers:

System ID: 479397NUTEX, 407PRMDMR, 828210VETMR, DZ3736MR01, DZ3048MR01, DZ3898MR01, DZ1033MR03, DZ2763MR01, DZ2416MR01, DZ1174MR01, DZ4681MR01, MR9988AR, MR4790AR, MR4652AR, MR2498AR, MR9874AR, MR9143AR, MRR10900, MR6013AR, MR1950AR, MR3050AR, MR8927AR, MR7221AR, MR9664AR, MR6931AR, MR3104AR, MR3642AR, AM1032MR01, 83194404670, 083027608484817, 083027603618122, 083027600102223, 083027600101523, 083027602480921, 083027601272821, 083027600102423, BA4188MR01, BW6016MR01, MRR5332, MRR4141, MRR6531A, MRRD0604, MRR2844, MRRD0991, MRR3439, MRR5861, MRRD1097, MRR5800, MRR3997, MRR4316, MRR1175, MRRD366, MRR10976, MRR049, MRR11573, MRR11608, MRR2667, MRR10693A, MRR11288, MRR7419, MRR5942, MRR7312, MRRD0685, MRRD0627, MRRD0381, MRR3619, MRRD0341, MRRD0494, MRR10881, MRRD0521, MRRD0671, MRR4146, MRR5666, MRR3673, MRR1940, MRR11258, MRRD1049, MRRD0476, MRR11477, MRRD0971, MRR3777, MRR7385, MRRD1008, MRR2924, MRR2459, MRRD1171, MRRD0840, MRR3579, MRR974, MRR1555, MRRD1027, MRRD0570, MRRD0751, MRRD1117, MRR6443, MRR1972, MRRD1376, MRRD1005, MRR11625, MRR11481, MRRD1149, MRR3633, MRR7215, MRRD0527, MRR5040, MRRD0738, MRR11243, MRRD0378, MRR1577, MRRD1091, MRR11242, MRR5941, MRRD0488, MRR5267, MRR11065A, MRR6333, MRRD1042, MRR11395, MRR10831, MRR135, MRR4005, MRRD0502, MRR5138, MRR3509, MRR142A, MRRD0356, MRR3558, MRR3433, MRR088, MRRD0518, MRR1333, MRR3652, MRRD1205, MRRD0469, MRRD0424, MRR276, MRYR2176, MRRD0545, MRRD0372, MRR11524, MRR5150, MRR1573, MRR2043, MRR11365, MRR5178, MRR11559, MRR11497, MRR6863, MRR11181, MRR2358, MRRD0587, MRR5082, MRRD1012, MRR192, MRR6655, MRR6554, MRR2760, MRRD0389, MRRD1032, MRR1024, MRR2476, MRR798, MRRD0659, MRR11057, MRR4972, MRR6939, MRR5747, MRRD1001, MRRD0577, MRRD0743, MRR2507, MRRD1164, MRR2226A, MRRD0598, MRRD0302, MRR11458, MRR425, MRR3730, MRRD1168, MRR493, MRRD1109, MRRD1062, MRRD0936, MRR1397, MRR4501, MRR2825, MRRD0430, MRRD0431, MRR11250, MRR10953, MRR10951, MRR10915, MRR2188, MRRD0567, MRR10671, MRRD0220, MRR11241, 6073MR0008, 6073MR0027, MRR1241, MR5865CL, MRR5926, MRR5749, MRRD0503, MRR5143, MR6264CL, MR8464CL, MRRD1116, MR9335CL, MR7528CL, MR2177CL, MRRD0978A, MRRD0541, MRRD0482, 082427110101, 082427110095, 082427110099, 082427040314, 082427040300, 082427040213, 082427220096, 082427220080, 082427220065, 082427220055, 082427220054, 082427070329, 082427100382, 082427070238, 082427290053, 082427200115, 082427210180, 082427100426, 082427090364, 082427090425, 082427200133, 082427100505, 082427120291, 082427200171, 082427310168, 082427160347, 082427130100, 082427200132, 082427160198, 082427290056, 082427100350, 082427270066, 082427270060, 082427070338, 082427070301, 082427090327, 082427290033, 082427060104, 082427060077, 082427040287, 082427040227, 082427210222, 082427120300, 082427120226, 082427120211, 082427200157, 082427200131, 082427120307, 082427010123, 082427020090, 082427080140, 082427080093, 082427060074, 082427060078, 082427270077, 082427010169, 082427010130, 082427070201, 082427140177, 082427020098, 082427020080, 082427050046, 082427050045, 082427080112, 082427080079, 082427080085, 082427190157, 082427210166, 082427310122, 082427310147, 082427230150, 082427230130, 082427200191, 082427200160, 082427200098, 082427310169, 082427120237, 082427190183, 082427090458, 082427160353, 082427160370, 082427160255, 082427310117, 082427120296, 082427100355, 082427190126, 082427230132, 082427200170, 082427030151, 082427260009, 082427270065, 082427080143, 082427200135, 082427080072, 082427080064, 082427040263, 082427140182, 082427140174, 082427140165, 082427260008, 082427310116, 082427160315, 082427030224, 082427030142, 082427070187, 082427160270, 082427150135, 082427150105, 082427100373, 082427120215, 082427100483, 082427100362, 082427130123, 082427280022, 082427170023, 082427100429, 082427100406, 082427100334, 082427160337, 082427140172, 082427310184, 082427140175, 082427140166, 082427160287, 082427110083, 082427100374, 082427100352, 082427090319, 082427100494, 082427100408, 082427010162, 082427180049, 082427020106, 082427020094, 082427180064, 082427120322, 082427120278, 082427120206, 082427070253, 082427070195, 082427020079, 082427150100, 082427250086, 082427140169, 082427100328, 082427230141, 082427120274, 082427160245, 082427210256, 082427100340, 082427030149, 082427190154, 082427140344, 082427310177, 082427090405, 082427180052, 082427200127, 082427060098, 082427060083, 082427060076, 082427070210, 082427190166, 082427090492, 082427090409, 082427090370, 082427090343, 082427090347, 082427220068, 082427220069, 082427220066, 082427020083, 082427020087, 082427020074, 082427190167, 082427190140, 082427080120, 082427160214, 082427160286, 082427270062, 082427260010, 082427030177, 082427090320, 082427090324, 082427200143, 082427200144, 082427210173, 082427210213, 082427010177, 082427010149, 082427010140, 082427010137, 082427220063, 082427150092, 082427150136, 082427150101, 082427150112, 082427290042, 082427290047, 082427290037, 082427160196, 082427160216, 082427160201, 082427160271, 082427160232, 082427160224, 082427160243, 082427160209, 082427160247, 082427160215, 082427160219, 082427160183, 082427160282, 082427160195, 082427160192, 082427160331, 082427160207, 082427180065, 082427180044, 082427180081, 082427180063, 082427240108, 082427240085, 082427240118, 082427170041, 082427210194, 082427070185, 082427070235, 082427070226, 082427070197, 082427070193, 082427070308, 082427070251, 082427070246, 082427070241, 082427070188, 082427070281, 082427070211, 082427070184, 082427070219, 082427070181, 082427010203, 082427010173, 082427010154, 082427010191, 082427010138, 082427010183, 082427090333, 082427090313, 082427090485, 082427090396, 082427090402, 082427090416, 082427090394, 082427090316, 082427090499, 082427090423, 082427090344, 082427090306, 082427090331, 082427090299, 082427090301, 082427090441, 082427090444, 082427090307, 082427090392, 082427090449, 082427090318, 082427090407, 082427090410, 082427190134, 082427210232, 082427210219, 082427210179, 082427210157, 082427210229, 082427190133, 082427190128, 082427190176, 082427190164, 082427190141, 082427190127, 082427190173, 082427190125, 082427060091, 082427120309, 082427120288, 082427120227, 082427120267, 082427120325, 082427120319, 082427120241, 082427200146, 082427200145, 082427200138, 082427200181, 082427200105, 082427200134, 082427200112, 082427200234, 082427200204, 082427200166, 082427200108, 082427200195, 082427020102, 082427020122, 082427020104, 082427030179, 082427030172, 082427030192, 082427030135, 082427030131, 082427060087, 082427060069, 082427060107, 082427060081, 082427060075, 082427060072, 082427300028, 082427300033, 082427300027, 082427300023, 082427280020, 082427280031, 082427280025, 082427280021, 082427170038, 082427210201, 082427250129, 082427230142, 082427200148, 082427060111, 082427010186, 082427010136, 082427010113, 082427190146, 082427230134, 082427290046, 082427160206, 082427090484, 082427140171, 082427190190, 082427230138, 082427100324, 082427210245, 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2472-2024

Related Recalls

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

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