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SIGNA Pioneer, with affected software versions: PX25.0 to… recallZ-2460-2024 · GE Medical Systems, LLC · initiated Jun 14, 2024

Class II Open, Classified All recalls posted in August 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION to its consignees via letter on 06/14/2024. The letter explained the problem with the device, safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: To ensure that the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit specified in the Low SAR Mode User Interface: " If your software version includes the Optimized T2 FLAIR Sequence option, enable this option by setting the value to 1.00. This option is present on the Advanced Tab of the Scan Prescription User Interface. " If your software version does not include the Optimized T2 FLAIR Sequence option, adjust scan parameters such as TR , # Slices or Auto Refocus Flip Angle until the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-2460-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 14, 2024
Posted by the FDA
Aug 2, 2024
Recalling firm
GE Medical Systems, LLC
Quantity
956 units
Product code
LNH
FDA submissions
K153003, K160621, K143345
Distribution
Worldwide distribution.

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

Code information (models, lots, serial numbers)

Show the full code information (12k characters)

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.

Other devices under the same FDA submission

2 devices cleared under K153003, K160621, K143345 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94874).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page