Z-2460-2024 Class II Ongoing

Recalled by GE Medical Systems, LLC — Waukesha, WI

FDA device recall Z-2460-2024 was initiated by GE Medical Systems, LLC on Jun 14, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 956 units.

Recall Details

Product Type
Devices
Report Date
Aug 14, 2024
Initiation Date
Jun 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
956 units

Product Description

SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, 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.

Code Information

System ID: 520744MR, 714578MR1, RADNETMR1727, RADNETMR652, 951486MR2, RADNETMR651, 831RMGMR1, RADNETMR647, RADNETMR661, 720442MR, 303508MR, 860584MR3T, 203694MR3T, 860678MR3T, 860545MR3T, 860536MR3T, 203327MR3T, 860871MR3T, 203949MR3T, 305933MR1, 954489MR2, 954492MR1, 407ODMR3T, 863577MR, 863607MR, 386385MR1, 850696MR3T, 954423MR2, RADNETMR1700, 850877PNR, 706PIONEER, 847459MR, 815215FDMR, 217223BHMR3T, 217QMG3TMR, 574SBOPIONEER, 318769MR2, 504LCMCHMR, 985WCMR3, 508872PMR, 508998MR, 413SHMR3T, 508775MR1, 781331MR, 508756PMR, 410266MR5, RADNETMR1719, RADNETMR1713, RADNETMR1708, 443481MR, RADNETMR1720, 301279MR4, RADNETMR1696, RADNETMR1724, RADNETMR1695, 828250MRW, 704362PIO, 704384PIO, 704333PIO, 919471DDIMR, 910483CI3T, 336397P3T, 856532MR, 908735PMR, 201796MR2, 973301MR3, 732462MRPNR, RADNETMR1711, 856231MR, SDMIADPMR1, SDMINWPMR1, SDMIBDPMR2, SDMICR3TPMR1, 718596MR, 718245MR, 631CHSPNR, 631858MR, RADNETMR1702, 315792MR, 516NYCB3T1, 516NYCB3T2, RADNETMR1704, 716278P3T, 516766MR3T, 631751MR, 518926MR3T, 518880MR, 516340MR3T, 315SDMG3T, 716656P3T, RADNETMR1707, 610402MR3T, 4603875-MDF035-1-1-1, 864225MR3T, 843681BL3T, 843797ARTMR, 8435563T, 843234MR3T, 843777PL3T, 843777PIO3T, 864255MMR, 803936LMCMR2, SPORTSMED3T, 423553MRD, 972747EAMR, 361275PIONMR, 469648EOT3T, 214320DFWD3T, 214954PCDMR, 469902EFM3T, 817741ENFW, 817592ESFW, 817433PHMR1, 830HCMPMR, 972805ENFMR1, 972495TSGMR2, 713512MHMR1, MHNEMR1, 972258HAMR1, 281HMI750W, RADNETMR678, 832638SCMR1, 512APIRRMR, 210MSNWPMR, 817424TSSL3T, 801ENVBMR3, 801377MR6, 757578GE3T, 262289MR1, LXTPMSW1NET, LXTT15NET, LXTT43NET, 307733MR, MR5314AR, MR3048AR, MR6508AR, MR6802AR, MR6623AR, MR52800461, 83203735240, 83183534632, 83183547990, 83141851264, 83183543071, 83144557293, 83178104799, 834MR000002, 83183539988, 834MR000005, 834MR000006, 83132425984, 834MR000050, 834MR000021, 834MR000015, 83155846100, 834MR000013MM4, 83210367946, 83178782037, 83201375088, 83152240359, 833MR000024, 833MR000024MM4, 83199160995, 83170864668, 83153235400, 083027603871918, 083027600728323, 083027600259223, 083027600101122, 083027607448619, BY4197MR01, 190207MR01, 110009MR01, 150019MR01, 110059MR01, MRUA2341, MRUA2246, MRUA0897, MRUA0751, MRUA0592, MRUA1533, MRUA2387, MRUA1058, MRUA2091, MRUA1977, MRUA1479, MRUA0790, MRUA2067, MRUA1053A, MRUA1135, MRUA2262, MRUA2182, MRUA1761, MRUA1746, MRUA0774, MRUA1294, MRUA2012, MRUA2303, MRUA2342, MRUA1595, MRUA1721, BG4605MR01, 403253MR1, 250598MR1, MR2470CL, MRUA1674, 082427110150, 082427110108, 082427110148, 082427040339, 082427040219, 082427040202, 082427040245, 082427220133, 082427230246, 082427090424, 082427010211, 082427010142, 082427060114, 082427100458, 082427100420, 082427290066, 082427030188, 082427160345, 082427160277, 082427070336, 082427070237, 082427090336, 082427240106, 082427040260, 082427040234, 082427040211, 082427150102, 082427020100, 082427080114, 082427060086, 082427140324, 082427050050, 082427050048, 082427100387, 082427200211, 082427090368, 082427070341, 082427260011, 082427250078, 082427080090, 082427030161, 082427030184, 082427140204, 082427030154, 082427100416, 082427100419, 082427090454, 082427100357, 082427010204, 082427100422, 082427250087, 082427030193, 082427090397, 082427090346, 082427220128, 082427020095, 082427100365, 082427030147, 082427010161, 082427290065, 082427290072, 082427160194, 082427160338, 082427160306, 082427160264, 082427160395, 082427160398, 082427160363, 082427160294, 082427180086, 082427240107, 082427240075, 082427240089, 082427170033, 082427170047, 082427210168, 082427210200, 082427090369, 082427070269, 082427070328, 082427070333, 082427070334, 082427070221, 082427070326, 082427070250, 082427070291, 082427070228, 082427070192, 082427070302, 082427070259, 082427070220, 082427010206, 082427010167, 082427010213, 082427090377, 082427090374, 082427090382, 082427090360, 082427090383, 082427090340, 082427090355, 082427090332, 082427090339, 082427090353, 082427090399, 082427090348, 082427090412, 082427210206, 082427190193, 082427190199, 082427190177, 082427190153, 082427190186, 082427190162, 082427190182, 082427190160, 082427120256, 082427120252, 082427120257, 082427120234, 082427200183, 082427200175, 082427200229, 082427200222, 082427200109, 082427200220, 082427200177, 082427200162, 082427020115, 082427020076, 082427020114, 082427200178, 082427030195, 082427030227, 082427030175, 082427030174, 082427030137, 082427030157, 082427020128, 082427190205, 082427160267, 082427130120, 082427160314, 082427010181, 082427150116, 082427130141, 082427130118, 082427130114, 082427210190, 082427010157, 082427070298, 082427090388, 082427060094, 082427040256, 082427040244, 082427040209, 082427120239, 082427180055, 082427200200, 082427200152, 082427200142, 082427090357, 082427200179, 082427200202, 082427060105, 082427090404, 082427080105, 082427050062, 082427050052, 082427160332, 082427160248, 082427160231, 082427310136, 082427160261, 082427230133, 082427220074, 082427200161, 082427180083, 082427240114, 082427240112, 082427310156, 082427030201, 082427030164, 082427220091, 082427220092, 082427220093, 082427090349, 082427100370, 082427170044, 082427140208, 082427110163, 082427110164, 082427100389, 082427090440, 082427090379, 082427160259, 082427020105, 082427070260, 082427100360, 082427100329, 082427200184, 082427060100, 082427080109, 082427020078, 082427240109, 082427070265, 082427090372, 082427090342, 082427220078, 082427190170, 082427100369, 082427300030, 082427020121, 082427160254, 082427230149, 082427100379, 082427100381, 082427100372, 082427100401, 082427100479, 082427100356, 082427100402, 082427040312, 082427100421, 082427100519, 082427100441, 082427100363, 082427100485, 082427100473, 082427080087, 082427310173, 082427310161, 082427230186, 082427230250, 082427230256, 082427230169, 082427050053, 082427140314, 082427130119, 082427130116, 082427130103, 082427250111, 082427060108, 082427060084, 082427040233, 082427040242, 082427040243, 082427040253, 082427040229, 082427040218, 082427040330, 082427040252, 082427020092, 082427020093, 082427020130, 082427020132, 082427230181, 082427230240, 082427230128, 082427230183, 082427230219, 082427230188, 082427230223, 082427050057, 082427300039, 082427300040, 082427110167, 082427110141, 082427110105, 082427110142, 082427110146, 082427110149, 082427100507, 082427100474, 082427100412, 082427100315, 082427100444, 082427100380, 082427100502, 082427100375, 082427100477, 082427100411, 082427100515, 082427100413, 082427080083, 082427080099, 082427080082, 082427080141, 082427080102, 082427080101, 082427080096, 082427080106, 082427080136, 082427160372, 082427160305, 082427160335, 082427160321, 082427040306, 082427160260, 082427160237, 082427160365, 082427160253, 082427160389, 082427180088, 082427270070, 082427120231, 082427120240, 082427120245, 082427120304, 082427120289, 082427120243, 082427120219, 082427120359, 082427120285, 082427120266, 082427120320, 082427200221, 082427200128, 082427200208, 082427200129, 082427200159, 082427200141, 082427200232, 082427200154, 082427200206, 082427200186, 082427200176, 082427200185, 082427070321, 082427070243, 082427070315, 082427070270, 082427070206, 082427070222, 082427070297, 082427090356, 082427090447, 082427090391, 082427090411, 082427090466, 082427090442, 082427090451, 082427090398, 082427140207, 082427140279, 082427140319, 082427140299, 082427140318, 082427140327, 082427140334, 082427170046, 082427190171, 082427150139, 082427150118, 082427240097, 082427240083, 082427030159, 082427030186, 082427030152, 082427030176, 082427030132, 082427030197, 082427220103, 082427310120, 082427280028, MRUA2207, MRUA2366, MRUA2102, MRUA1732, FI1529MR01, FI1528MR01, 6630605, X868131018, M6013235, M4170017, M1220510, X151054618, 7893365, X832010008, M4186544, M523012201, 8124342, X180293403, 8477706, X70053501, B1020811, M2850024, M4201126, M6031213, X180555401, 6368777, GE1192MR01, UC1590MR05, 125528MR01, PC0127MR05, PC3741MR02, 477494MR02, 102207MR01, PC7479MR11, 164236MR01, 805466MR02, P00042MR02, 519659MR02, PC0396MR09, 158049MR01, TP0013MR01, PNUE04MR02, 157022MR01, 102208MR01, 262634MR01, PVIL01MR03, TP0008MR07, H1039MR59, H1349MR09, H12661MR01, MRUA2146, HU1573MR01, 083027001694718, 083027001004517, 083027249332422, 083027823408018, 083027800000000, 083027823888617, 083027828002316, 083027300000000, 083027206246319, 083027203606423, 083027217993720, 083027202667719, 083027219689319, 083027205107016, 083027204286118, 083027216245319, 083027287472616, 083027603021621, 083027049490119, 083027044418917, 083027804401220, 083027800993718, 083027809324716, 083027809620621, 083027841881218, 083027848334618, 083027843598318, 083027843057922, 083027029818718, 7982MR0035, 7982MR0052, 7982MR0018, 5512MR0020, 7982MR0025, 7982MR0046, 7982MR0015, 7982MR0042, 7982MR0037, 7982MR0028, 5512MR0023, 7982MR0010, IE1111MR02, A5248814, B5142305, A6012606, A5192422, A556284807, A5265815, 9734221, 9046395, A5129130, A5323816, A5811312, A5634625, A5383109, A5725519, A5328313, MR1938JM, ZC0318, ZC0302, ZC0015, ZC0037, ZC0306, ZC0002, MR00069, MR00070, ZC0003, MR00134, ZC0016, ZC0301, MR00115, ZC0020, ZC0001, ZC0305, MR00090, ZC0009, ZC0008, ZC0312, MR00081, ZC0038, MR00051, ZC0025, ZC0035, ZC0018, ZC0026, ZC0304, ZC0012, ZC0007, ZC0006, ZC0315, ZC0010, ZC0011, ZC0021, ZC0004, ZC0027, ZC0028, ZC0014, ZC0030, ZC0034, ZC0307, ZC0013, ZC0022, ZC0309, ZC0017, MR00025, ZC0029, ZC0019, ZC0319, ZC0308, ZC0313, MR00151, ZC0314, ZC0024, ZC0032, MR00080, ZC0036, ZC0031, ZC0023, ZC0033, ZC0303, MR00046, KE6280MR01, 0850270796, 0850270773, 0850270699, 0850270615, 0850270582, 0850270764, 0850270731, 0850270681, 0850270702, 0850270795, 0850270740, 0850270713, 0850270579, 0850270587, 0850270585, 0850270707, 0850270610, 0850270603, 0850270583, 0850270529, 0850270512, 0850270486, 0850270700, 0850270623, 0850270624, 0850270535, 0850270717, 0850270640, 0850270690, 0850270655, 0850270638, 0850270632, 0850270608, 0850270621, 0850270489, 0850270778, 0850270710, 0850270706, 0850270599, 0850270488, 0850270657, 0850270547, 0850270629, 0850270530, 0850270659, 0850270631, 0850270687, 0850270688, 0850270597, 0850270605, 0850270762, 0850270722, 0850270724, 0850270715, 0850270662, 0850270661, 0850270626, 0850270580, 0850270753, 0850270581, 0850270539, 0850270784, 0850270780, 0850270804, 0850270793, 0850270561, 0850270752, KW1100MR03, MR52182291, LB1040MR03, LT4111MR01, LT4124MR01, MR52002481, MR52630931, MR52692081, LT4079MR02, MC1024MR02, 1553MR0015, 1553MR0025, MRUA2360, MRUA2351, MRUA2359, MRUA1070, MRUA2353, MR53818491, 6073MR0023, OM1011MR02, MRUA0646, MR1881PY, 1557MR0038, 1557MR0021, P00021MR01, P00007MR03, PL1751MR02, PL1692MR01, PL3811MR01, PER00497, PPS39214, PPS17604, MRUA1939, RO1115MR02, RO1686MR01, RO1681MR01, RO1547MR01, RO1205MR02, RO1046MR01, RO1669MR01, RO1568MR01, RO1642MR02, RO1508MR04, RU3563MR01, RF0066MR01, RU3508MR02, RF2612MR01, RU1282MR02, RU3356MR01, RU1516MR02, RU1834MR03, RF1085MR01, RU0301MR01, 600100MR05, RU1449MR02, RU1463MR02, 600105MR02, RU2592MR01, RU0680MR01, SA1133MR01, RS4156MR01, ZA2240MR02, ZA3171MR01, NPV27710, YP158330, MPX57800, NPV73518, FPD24003, CE270967, MPX43810, DPN62303, DPD15901, MPX39941, MEX61793, MPX60700, CPM80623, MP842036, FPG30548, NPV15985, O012MR02, N006MR03, 899010MR04, 529170MR02, 160886MR01, 0899010MR04, 265050MR05, 724010MR05, 697040MR02, 146806MR01, 121497MR02, 501032MR01, 167187MR01, 334963MR01, 779205MR01, 725030MR02, 259200MR02, 222768MR01, 115030MR02, 0853270195, 0853270167, 0853270203, 1573MR0010, 1573MR0041, 1573MR0028, 1573MR0060, TN2000MR01, 06048MRS01, 06184MRS05, 06184MRS01, 06184MRS04, 16039MRS02, 41053MRS01, 34340MRS02, 34173MRS02, 34026MRS05, 35117MRS01, 33044MRS01, 09004MRS01, 34185MRS02, 34225MRS02, AE1190MR02, AE1149MR01, 11073MRS01, 11161MRS01, 10627MRS02, 77990MRS01, 00313MRS02, MRUA1991, 5973MR0021, 5973MR0044, 5973MR0030, 5973MR0048, 5973MR0038, 5973MR0017, 5973MR0033, 5973MR0102, 5973MR0108, 5973MR0008, 5973MR0046, 5973MR0013, 5973MR0084, 0850270802, VNMR54372061, 082427130204.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2460-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.