SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to ...
FDA Device Recall #Z-2459-2024 — Class II — June 14, 2024
Recall Summary
| Recall Number | Z-2459-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 14, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 834 units |
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
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.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
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.
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| Z-1571-2026 | Class II | Centricity Universal Viewer Software Versions 5... | Jan 30, 2026 |
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.