SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, 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: 907ULMC3T, 907264MR, 907729ANMR, 907580MR, 907796JMR, 907443MR, 205SBMR, 256ALIPM450, 256ALOPMR, 205934CVMR, 205BVAMR2, 205BVAMR1, 205592MR4, 205783MR3, 256768MR450, 205608MR, 256265STMR, 256SRIPM450, 256CCIMR1, 256HHMR3, 256MHMR1, 334286BSMR, 256386AV450, 334358MR2, 501661VA450, 928639MR1, 602588MR2, 623882MR, 520OVHMR, 602655MR1, 602406MR5, 602532MR, 623683MR1, 602277VAMR1, 602923MR, 928445MR1, 480324MR, 520USCMR1, 520UMIMR, 530332MR, 760370MR2, 559225VAMR450, 818790MR1, 562531MR, AVHLMMR, 805737MR2, 760631DVMR1, K10276, 415723CHMR4, 530MHMR, 650847KMR2, 650847KMR1, 951788MR2, UCDROCKMR, 916783450MR2, 916784MR3, 916KCIRBYMR, 916RASSMR, 916KJMR, GON5381894, 10835, 619543MR3, 858453VMR3, 415CPCHMR3, GON5429076, GON5429078, 415ARTKSRFMR, AVHTRMR1, 530SNMR2, 303695MR2, 303839MR1, 303837MR1, 3038998MR, 303788MR, 719524DVMR, 970945450W2, 970CPKMR450W, 970945450W, 970244AMPMR, 970RMOMR, 303SKYMR3, 303651MR, 303964MR, 719333MR2, 203739MR450W, 860545MRART2, 860545MRART1, 203276ART, 860231MR, 302744MR, 302430MR, 941798MR2, 813685MR, 954916MR2, 904321MR2, 376VAMR1, 904202MR18, 904202MR6, 904202MR17, 904202MR16, 904627MR2, 561844MR2, 321VHARTIST, 321HRARTIST, 321HF450W, 305223MR3, 305642MR1, 305665MR450W, LKNONAMR1, FHEARTIST2, FHEARTIST1, 386PCMR, 321PBARTIST, 4817325MR11, 850747DVMR, 813844MR2, 813844MR, 813745MR6, LMCPMR, 727834MR, HSSWPBMR450W, 561697MR1, HWARTIST, 229312MMRI, 706ARTISTMR, 404778MR1, 404778MR2, 404605MR, 706733MR, 706651AMR, 706651MR, 912466MR1, 706571MR, 3016508, 912435MR, 706692PJMR2, 678474JCMR2, 404605PKMR1, 770914MR, 912350CHOSMR, 912350GEMR, 229228ARTIST, 3012383, 808HMCMR, 808KMAPMR, AVHCSMR, 515643MR1, 319268MR, 563387MR, 515643MR450, 563584MR, 712264MR2, 712213MR, 319768GRMR1, 563422MR, 208422MR1, 208524MR, 208529MR1, 208557MRI, 208743ART, 208463SZMR, 208265BGMR, SLMVMR450, 847618MR2, 1000001238, 312947MR, 312702MR450, 217342BMR1, 847437AMR1, 1000003614, SMSOMR3, 618997VAMR1, 618288DVMR, 618288OWMR, 217258SBMR2, 708LOYMR2, 1000004956, 630326MR, 630953MR, 708349MR, 1000000047, 1000004953, 217BHC450W, 217528MR2, 630933MR, 630933MR3, 260665MR, 317582MR2, 812376MR1, 260432MR, 260425MRI, 765453MR, 219326MR450W, 574753ARTIST, 219877MR, 812842MR3, 812385MR1, 574223MR450W, 812522MR2, 574284MR, 785623HMRA, 913MMCMR, 913469CPMR, 913541OMR, 913676SMRW, 316858MRA, 316962WMRA1, 316962MR450, 606833MRW, 502350MR, 270798MR1, 606678ARTMR, 318448MR, 225OHGMRI, 318681CBMR, 985LVMR1, 504OKMR, 985785MR, 504TOURMR, 504CHMR15, 318681ARTIST, 985NSMRI, 225658LMR, ANGELLMR1, 617726MR1EL2, 617726ERMR, 978882MR1, 781340MR3, 413584MRART, 508693MVMR, 5427030MR41_TEMPUPGSID, 781SSHMR1, 781340MR2, 413794MRART, 781729MR, UMASSWORCMR2, 508363MR, 443843MR1, 240555AMR, 240964ARTIST, 240683MR, 410787MR1, RADNETMR1548, RADNETMR1703, RADNETMR1705, 301618MR2, 207MIDCOASTMR, 207778ARTIST, 207INTERMEDDVMR, 734845VA450MR, 313745ART2, 313745ART1, 810762MR, 810606ART, 517HILLMR, 517788ART, 269341ART, 906225ART1, 906225ART2, 989583ARTIST, 248849ART, 218333MR1, 763CDIARTMR, 218249ART15, 507238MR1, 320693MR, MR1114440, MR1046092, MR1114463, MR1045974, MR1004372, MR229063, 320251ART, 636256MCV450W, 816BRMCMR, 573815MR3, 573884MR15, 816CP450W, 816861AMR, 816276MRW, 636379MERCYMR, 314MERCYOPMR2, 314525MCCMR, 314251MMR5, 601668SIGNA, 228575MR, 601288DVMR2, 601268WDVMR, 601288DVMR, 228818DVMR, 662932ART, 228BIENDVMR, 406375HMR, 406751KART, 406327AMR, 406543ART, 704984DVMR, 828213MRW, 704863ART, 704667MR450, 704446DVMR, 704384BALL, 704304DVMR, 910470ART1, 919684DMPMR1, 919684CC450W1, 910907WAMR3, 828349AMCMR, 336832MR1, 252VMCART, 828659MRW, 980993ART, 336719MR, 919954RMR2, 252NDMR450W, 704487ART, 252VBART, WMCGEMR, 701857MR, 402228MR, 402926NHI, 402362DVMR, 603334ART, 603332ART, 603952MR1, BRMR2, 908828MR, 732836MRART, 732222MRART, 973971MR4, MSF169-1-6XRM9S2F, 973971MR450W, 973971MR2, 732745MR, 973579MR, 732747VETMR, 201447MRW, 856582MR, 856247MR2, 505998ARTMR, 505888MR, 505609MR, 575521MR1, SHIMR02616, 775SIERRAMR, 702880MR450W, 702731MR3, SUNRMR1, 702962MR2, 518262ARTIST1, 518262ARTIST2, 585343MR1, 631665MR450, 585758MR, 718963MR2, HSSBKMR450W, 716845MR2, 716862MR1, 518371MR, 315UBJART, MAINARTMR, 315LCGHMR, SINAI9MR450W, MSK68CIGIMR01, HSSMRIB, SINAI8MR450W, 212744MR1, 212939MR1, 212562MR2, MSKDHKMR1, HSSWSMR450W, HSSMAGNETA, COR586479, RADNETMR1689, MSK65MR3, 845348MR, 516763ART, 845454MR, 631548MR, 585785MR2, 585214MRAO, 585275MR3, 585275MR1, 585723UNITYMR, 585HIGHLANDMR, 585266MR2, 518382MRI, 518243MR, 516798MR, 718226MR2, 914631MR15T, 914681MR15T, HSSWPMR450W, 330489MR450W, 330363450W, 330363MR, 513584MR1, 513556VVMR, 513MWMR2, 614722MR1, 614293MR8, 937208MR2, 937641MR, 330342MR, 419LIMAMEMMR2, 419893MR, 740393MR2, MHSPRGEMR2, 419383ARTMR, 419407MR1, 330746MR, 740455MR, 580272MR2, 580272MR, 580223AMR, 580251MR1, 580548BWB, 405329NMR, 405755MR1, 405636SMR1, 405751MR3, 918458MR3, 918458MR1, 918458MR2, 918567MR2, 918367MR, 918502MR6, 918502MR4, 918502MR5, MSF169-1-6XXYDCOS, 918502MR3, 918286MR, 918256MR, 580774WMR, 503253MR1, 503813MR1, 503513PMMR1, 503537PNMR2, 503216SVMR1, 503215PPMR1, 503215PPMR2, 503216SVMR2, 503717SSMR1, 610740MRER, 814889MRART, 570645MR1, 724772MRART, FITZMR, 484822MR, 610333MR, 717334MR1, 717632MR1, 724357MRART, 814262MR15T, 484464MR, 412622MRART, 272639MR, JCIVOYAGER, 215955MR3G, 215FCCC450W, JEFFNAVY, JEFFCOB450W1, 412835MR1, 267985MR, 610628MR, 814237MR450W, 215674OP450W, 412650MRART, 570321MR, 610988MR2, 717812MR, 864512MR1, 843402ART, 843724ART, 843847MR, 803461MRI, 803313ART, 864487UPMR, 864227MR2, 864560PMR, 803313DVMR1, 843390MR, 843606MPMR, 843416ARTIST, 843692GSART, 843832SMR, 843549ART, GON5151028, 605256MR450W, 605995MR, 605341MR1, 605322MR3, 615446ART1, 615771MRMD, 901GTOPMR1, 615338ART1, 615SMTOPMR1, 615SUMMITMR2, 615SUMMITMR, 423794MR, 865305MR, 901523ART, 901227ART, 901516ART3215, 901516ART15, 423926MR1, 423926MR2, 615769MR2W, 615SCMR2W, 512BSWSAMR, 956350MRW, 325646MR, 512BSWBUDAMR, 817517MR1, 713790MR2, 832912MR1, 281758MR355, 972566MR1, 972566MCHSMR, 214276MR1, 830VVARTMR, 940536EDMR1, 214420CDIDMR, 806935MRI450W, 915832HOPE, 915577ARTIST, 817AMERMR1, 817922ADIMR1, 972497BSFMR2, 830426MCMR, 713527MR1, 713ACB4MR24, 713442KSMR6, 713442MR1, MHMOBILEMR1, 713442KSMR5, 281333MR3, 281588MR, 713442KSMR4, 713792AMR21, 713441MR10W, 281NWARTIST, 713791VAMR1W, 512SHMRI, 806UMCWM15T, 956632ARTIST, 972540MMWMR1, 469815BCMR1, 936568HDX, 972596MCPMR2, 972596MCPMR1, 972617REDMR1, 512341MR3, 210VHSART, 936275SAMR1, 713897MWMR1, 817424ESLMR1, 713442KSMR8, 713442FTBNDMR1, 972798ESWMR1, 936271MR2, 281401MR1, 903533HDXT, 361572CICMR, 254751PMR1, 817599WRMR1, 713442CLMR1, 801756MR2, 801299MR2, 435BCMR, 801LONEMR1, 435HEBERMR1, 435635MR1, 801LAYMR2, 801LAYMR1, 435623MR2, 801MCDMR1, 801714MR1, 435PARKARTISTMR2, 801465MR2, 801373MR4, 435893MR1, 801RIVMR3, 435251MR2, 801LEHIMR1, 801588MROR, 801268MRARTIST, 801588MR01, 801SSMR, 801SPFRKMR1, 276258MRART, 703204MR1, 804CHEDMR, 434799ART, 703573ART5, 703391MR1, 703805MR2, 5101520MR81, 540SRMCMR, 703573ART8, 703858MR1, 703205MR3, 804764MR450W, 804SF450W, 703689MR, 804225MR, 804JWSPMR, 804281450W, 540776MR, 757673MRART, 802775MR, 425637VM450MR, 509765MR, 509332MR450W, 425486EVMR, 206744HMR, 360744HM450MR, 509474SH15T, 509434ART, 509473ART, 509482MR2, 715838MR1, 920288MR2, 920406HDX, 608262MR2, 608ONCMR1, 608VAARTIST, 608262MR3, 608287MR1, 715735MR1, 414805MR7, 920729ARTIST, MR1020321, 920208MR1, 715346MR1, 608372MR, SHIMR02613, SHIMR02611, SHIMR02651, 920262MR2, 414778MR1, 262429MR1, 304255VMR2, 304766MR4, 304526SMR2, DZ4953MR01, MR6033AR, MR3158AR, MR8772AR, 0910272091, 0910272093, 83195528655, 0910274042, 83202332947, 833MR000019, 83185224328, 83211314049, 833MR000035, 833MR000032, AH7084MR01, 130083MR06, 190194MR01, 190052MR01, 080026MR04, 030020MR03, 030151MR02, 080038MR01, 019022MR01, 019022MR07, 080100MR01, MRPM0227, MRPM0122, MRHM2195, BA4017MR01, MRHM2198, MRHM2005, MRHM1985, MRPM0952, MRPM0126, MRHM1900, MRR7938, MRPM0178, MRHM2122, MRPM1089, MRR10280, MRHM2039, MRHM1996, BG4042MR01, 902465MR, 905522MR1, 613632MR1, KWMRIHDXT, 604534MRART, 403382MR1, 604463MRART, 506623MR1, 506857MR2, 514934MR3, E416249MR3, 514697MR1, 905684MR1, 506648MR3, 902567MR, 250370ARTIST, 514939MR2, 514939MR1, 416756MR2, 902470MR, MRHM2116, MR2651956V2, MR6447CL, MRHM2245, MRHM2207, MRHM2249, 37448269MR, MR6746CO, DK1001MR01, DK1044MR04, DK1044MR06, DK1044MR07, DK1044MR08, DK1029MR05, DK1030MR05, DK1030MR04, DK1567MR01, DK1296MR01, MR6826DO, EG1194MR01, EG2650MR01, EG2646MR01, EE4019MR04, EE4019MR03, FI1075MR01, FI1120MR01, FI1693MR01, FI1175MR01, FI1052MR02, X121122501, M2002652, 06825989, S41600139, S4160096, M4161669, X616953011, M4409451, M4164350, M373312701, A2032125, X1478403, M4018553, M4016052, A4167357, X4479206, M4167842, M220648614, M2740512, 08607638, 07290913, F4171514, M4016577, M4020545, 05803166, 05840914, M2148263, M4490023, 05841009, X59655535, A62925713, X2007313, X629257022, M4173507, 07616398, M4174556, 06283325, M23084341, M178899204, A178899201, X1617001, X106415412, 06442791, M1425524, M4216461, 05803153, M4548544, X756087027, M4183857, X90281622, X967501009, M1656640, M24313807, H68439574, X401876904, C21952109, M4144365, 07335100, M4459621, X2181508, 07893363, M4631109, M4499039, 06889963, M5480794, A4194463, M4134656, M40330128, M4037076, M2637327, M1400959, 07809641, A9190175, M9708014, M206565705, 07307575, M54849101, 06442787, M40345203, M176430616, M5484987, M22635307, A9190184, A9502027, M54606128, M2634911, M2634913, M215517204, A1588529, M4200637, X354818502, 9913017, M178710409, M41439106, M4484752, M2322266, M1460212, M401886301, X118196008, H4858987, M4210251, M4210253, M4475682, X4211056, M2848452, 6278434, M42155110, M42155108, M42155103, X220730403, M226407304, M45052120, 9063097, 7838453, 129619MR01, HC6051MR01, 125995MR01, 351482MR01, PC7479MR10, PC8740MR02, HJJH01MR01, PC1455MR02, PC0396MR11, 123702MR01, HC7498MR03, HC3702MR01, HC1770MR03, HPAD01MR01, HC3996MR03, UC1559MR03, PC3312MR02, GON5402630, H10392MR52, H1943MR12, 0828270052IB01, 0828270065, 0828270056IB01, 0828270063, 0828270053IB01, HU1677MR01, 083027001002910, 083027004207919, 083027002227411, R83027204626924, R83027244108223, 083027060255422, 083027009119914, 083027824772621, 083027821317819, 083027202100488, 083027201013310, 083027205726822, 083027208006511, 083027206937710, 083027064149415, 083027043313421, 083027808143521, 083027847234115, 083027847898022, 083027021913318, 083027021866615, 083027000042713, IR2452MR01, MR50351941, IE1265MR01, A5127236, A5992703, A5649021, A5130628, A5165733, A5624157, A5315597, A670060237, 09509308, A258001703, A127292419, C5323541, A51529243, D5249954, A5105766, A5314615, A5401395, EM0808, EM0924, EM0930, MR00078, GON5441641, EM0921, MR00087, EM0802, EM0805, EM0814, EM0918, EM0901, MR00245, EM0917, EM0809, MR00008, EM0811, EM0803, EM0812, EM0905, EM0801, MR00088, MR00208, MR00086, EM0902, EM0807, EM0815, MR00221, MR00012, EM0800, EM0907, MR00166, MR00158, MR00217, EM0925, MR00001, MR00056, MR00005, EM0804, EM0810, EM0900, MR00237, MR00238, MR00156, EM0915, EM0926, MR00230, EM0813, MR00248, MR00037, EM0806, MR00242, EM0911, 0850270460, 0850270538, 0850270432, 0850270323, 0850270317, 0850270227, 0850270636, 0850270395, 0850270307, 0850270399, 0850270298, 0850270449, 0850270157, 0850270224, 0850270664, 0850270714, 0850270428, 0850270513, 0850270127, 0850270173, 0850270278, 0850270424, 0850270065, 0850270389, 0850270314, 0850270252, 0850270133, 0850270789, KW1013MR06, KW1013MR07, KW1013MR08, KW1013MR05, KW1001MR04, KW1008MR05, KW1008MR06, KW1008MR07, KW1002MR01, KW1007MR05, KW1007MR04, KW1006MR04, MR52660981, MR52660991, MR52661284, MR51319271, MR51319281, KW1003MR01, KW1112MR01, KW1004MR04, KW1155MR02, 080017MR02, 080017MR01, 110807MR03, 110807MR02, 030013MR05, 0834270016, MRR9771, 2884783MR, MRR11569, MRHM2073, MR52993021, MR52992811, MA1877MR01, RTD01203, RTD01202, 85114777250, 859MR000011, 85155343850, 85177987565, 859MR000025, NO1011MR02, OM1007MR02, PK1035MR01, MR8375PE, MR2323PE, MR4604787PE, 1557MR0034, PL1476MR02, PL1584MR02, PL0551MR02, PL1580MR02, PL1689MR01, PL1661MR01, PL1698MR01, PL1312MR03, PL1312MR02, 600034MR01, PL2201MR01, PL3376MR01, PL1150MR02, PL1234MR01, 600042MR03, PL1169MR02, PL3254MR01, PER08329, PPR29816, MR1730PR, MR7598PR, MR53527301, RO1079MR01, RU9571MR01, RU1156MR01, RU1095MR04, RU7984MR01, RU1128MR02, RU1128MR01, RU3509MR01, RU1296MR02, RU2275MR01, RF2817MR01, RF1383MR01, RF0929MR02, RF3309MR01, SA2706MR01, SA2633MR01, SA1039MR03, SA2308MR01, SA1209MR01, SA1012MR06, SA1034MR04, SA2643MR01, MR51994661, RS4060MR01, RS4199MR02, RS4199MR03, RS4095MR02, 6073MR0042, 6073MR0049, 6073MR0045, 6073MR0041, ZA1374MR01, DEN272171, DEN272172, NPD29701, FPG103200, MPX82200, CPZ38301, NE203172, CE270998, FEC800342, FE421194, FED03936, UE929541, DE492A102, DED647172, DE5284115, DPN89122, DE5284116, DPD15902, DED647131, DPB15881, DPN26335, DEK78891, CEG94657, MEX617112, CPZ09633, CE165375, UPW25212, FE457A208, NEV439244, NP473633, NPV22537, NP473629, CPI21217, A004MR04, A004MR06, O009MR04, M007MR01, N004MR01, M001MR01, N002MR04, 788000MR01, 492360MR01, 121351MR01, 123953MR02, 850020MR03, 0853270191, 0853270231, 0853270194, 0853270207, 0853270213, 0853270228, 0853270197, 0853270215, 0853270198, 0853270217, 0853270232, 0853270209, 0853270199, 0853270225, 0853270204, 0853270205, 1573MR0043, 0856270046, 1573MR0009, 1573MR0027, 1573MR0033, TN1059MR02, TN1166MR01, 01085MRS01, 34727MRS01, AE1485MR01, AE1367MR01, AE1626MR01, 00487MRS03, 70001MRS12, 77624MRS05, 77624MRS07, 00222MRS02, 00243MRS09, 00243MRS06, 10572MRS02, 77055MRS04, 00109MRS01, 00440MRS09, 00740MRS03, 10223MRS01, 00507MRS02, 00130MRS04, 10044MRS03, 00203MRS02, 00203MRS01, 10627MRS01, 00025MRS02, 00025MRS01, 10307MRS05, 70383MRS06, 70043MRS06, 11187MRS02, 00023MRS02, 01050MRS01, 70065MRS05, 00230MRS02, 00131MRS02, 00263MRS05, 00020MRS07, 00020MRS03, 00223MRS04, 05249MRS01, 00240MRS02, 10433MRS01, 00244MRS02, 00674MRS02, 907ULMCARTIST, MRPM1147, MRPM0735, MR4362UY, 5973MR0009, 303467MR1, 570501MR1, 11923362, 0828270037IB02, 407303MRER (w/ EVO upgrade), 214420MR1 (w/ EVO upgrade).
  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 Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Product Codes/Lot Numbers:

System ID: 907ULMC3T, 907264MR, 907729ANMR, 907580MR, 907796JMR, 907443MR, 205SBMR, 256ALIPM450, 256ALOPMR, 205934CVMR, 205BVAMR2, 205BVAMR1, 205592MR4, 205783MR3, 256768MR450, 205608MR, 256265STMR, 256SRIPM450, 256CCIMR1, 256HHMR3, 256MHMR1, 334286BSMR, 256386AV450, 334358MR2, 501661VA450, 928639MR1, 602588MR2, 623882MR, 520OVHMR, 602655MR1, 602406MR5, 602532MR, 623683MR1, 602277VAMR1, 602923MR, 928445MR1, 480324MR, 520USCMR1, 520UMIMR, 530332MR, 760370MR2, 559225VAMR450, 818790MR1, 562531MR, AVHLMMR, 805737MR2, 760631DVMR1, K10276, 415723CHMR4, 530MHMR, 650847KMR2, 650847KMR1, 951788MR2, UCDROCKMR, 916783450MR2, 916784MR3, 916KCIRBYMR, 916RASSMR, 916KJMR, GON5381894, 10835, 619543MR3, 858453VMR3, 415CPCHMR3, GON5429076, GON5429078, 415ARTKSRFMR, AVHTRMR1, 530SNMR2, 303695MR2, 303839MR1, 303837MR1, 3038998MR, 303788MR, 719524DVMR, 970945450W2, 970CPKMR450W, 970945450W, 970244AMPMR, 970RMOMR, 303SKYMR3, 303651MR, 303964MR, 719333MR2, 203739MR450W, 860545MRART2, 860545MRART1, 203276ART, 860231MR, 302744MR, 302430MR, 941798MR2, 813685MR, 954916MR2, 904321MR2, 376VAMR1, 904202MR18, 904202MR6, 904202MR17, 904202MR16, 904627MR2, 561844MR2, 321VHARTIST, 321HRARTIST, 321HF450W, 305223MR3, 305642MR1, 305665MR450W, LKNONAMR1, FHEARTIST2, FHEARTIST1, 386PCMR, 321PBARTIST, 4817325MR11, 850747DVMR, 813844MR2, 813844MR, 813745MR6, LMCPMR, 727834MR, HSSWPBMR450W, 561697MR1, HWARTIST, 229312MMRI, 706ARTISTMR, 404778MR1, 404778MR2, 404605MR, 706733MR, 706651AMR, 706651MR, 912466MR1, 706571MR, 3016508, 912435MR, 706692PJMR2, 678474JCMR2, 404605PKMR1, 770914MR, 912350CHOSMR, 912350GEMR, 229228ARTIST, 3012383, 808HMCMR, 808KMAPMR, AVHCSMR, 515643MR1, 319268MR, 563387MR, 515643MR450, 563584MR, 712264MR2, 712213MR, 319768GRMR1, 563422MR, 208422MR1, 208524MR, 208529MR1, 208557MRI, 208743ART, 208463SZMR, 208265BGMR, SLMVMR450, 847618MR2, 1000001238, 312947MR, 312702MR450, 217342BMR1, 847437AMR1, 1000003614, SMSOMR3, 618997VAMR1, 618288DVMR, 618288OWMR, 217258SBMR2, 708LOYMR2, 1000004956, 630326MR, 630953MR, 708349MR, 1000000047, 1000004953, 217BHC450W, 217528MR2, 630933MR, 630933MR3, 260665MR, 317582MR2, 812376MR1, 260432MR, 260425MRI, 765453MR, 219326MR450W, 574753ARTIST, 219877MR, 812842MR3, 812385MR1, 574223MR450W, 812522MR2, 574284MR, 785623HMRA, 913MMCMR, 913469CPMR, 913541OMR, 913676SMRW, 316858MRA, 316962WMRA1, 316962MR450, 606833MRW, 502350MR, 270798MR1, 606678ARTMR, 318448MR, 225OHGMRI, 318681CBMR, 985LVMR1, 504OKMR, 985785MR, 504TOURMR, 504CHMR15, 318681ARTIST, 985NSMRI, 225658LMR, ANGELLMR1, 617726MR1EL2, 617726ERMR, 978882MR1, 781340MR3, 413584MRART, 508693MVMR, 5427030MR41_TEMPUPGSID, 781SSHMR1, 781340MR2, 413794MRART, 781729MR, UMASSWORCMR2, 508363MR, 443843MR1, 240555AMR, 240964ARTIST, 240683MR, 410787MR1, RADNETMR1548, RADNETMR1703, RADNETMR1705, 301618MR2, 207MIDCOASTMR, 207778ARTIST, 207INTERMEDDVMR, 734845VA450MR, 313745ART2, 313745ART1, 810762MR, 810606ART, 517HILLMR, 517788ART, 269341ART, 906225ART1, 906225ART2, 989583ARTIST, 248849ART, 218333MR1, 763CDIARTMR, 218249ART15, 507238MR1, 320693MR, MR1114440, MR1046092, MR1114463, MR1045974, MR1004372, MR229063, 320251ART, 636256MCV450W, 816BRMCMR, 573815MR3, 573884MR15, 816CP450W, 816861AMR, 816276MRW, 636379MERCYMR, 314MERCYOPMR2, 314525MCCMR, 314251MMR5, 601668SIGNA, 228575MR, 601288DVMR2, 601268WDVMR, 601288DVMR, 228818DVMR, 662932ART, 228BIENDVMR, 406375HMR, 406751KART, 406327AMR, 406543ART, 704984DVMR, 828213MRW, 704863ART, 704667MR450, 704446DVMR, 704384BALL, 704304DVMR, 910470ART1, 919684DMPMR1, 919684CC450W1, 910907WAMR3, 828349AMCMR, 336832MR1, 252VMCART, 828659MRW, 980993ART, 336719MR, 919954RMR2, 252NDMR450W, 704487ART, 252VBART, WMCGEMR, 701857MR, 402228MR, 402926NHI, 402362DVMR, 603334ART, 603332ART, 603952MR1, BRMR2, 908828MR, 732836MRART, 732222MRART, 973971MR4, MSF169-1-6XRM9S2F, 973971MR450W, 973971MR2, 732745MR, 973579MR, 732747VETMR, 201447MRW, 856582MR, 856247MR2, 505998ARTMR, 505888MR, 505609MR, 575521MR1, SHIMR02616, 775SIERRAMR, 702880MR450W, 702731MR3, SUNRMR1, 702962MR2, 518262ARTIST1, 518262ARTIST2, 585343MR1, 631665MR450, 585758MR, 718963MR2, HSSBKMR450W, 716845MR2, 716862MR1, 518371MR, 315UBJART, MAINARTMR, 315LCGHMR, SINAI9MR450W, MSK68CIGIMR01, HSSMRIB, SINAI8MR450W, 212744MR1, 212939MR1, 212562MR2, MSKDHKMR1, HSSWSMR450W, HSSMAGNETA, COR586479, RADNETMR1689, MSK65MR3, 845348MR, 516763ART, 845454MR, 631548MR, 585785MR2, 585214MRAO, 585275MR3, 585275MR1, 585723UNITYMR, 585HIGHLANDMR, 585266MR2, 518382MRI, 518243MR, 516798MR, 718226MR2, 914631MR15T, 914681MR15T, HSSWPMR450W, 330489MR450W, 330363450W, 330363MR, 513584MR1, 513556VVMR, 513MWMR2, 614722MR1, 614293MR8, 937208MR2, 937641MR, 330342MR, 419LIMAMEMMR2, 419893MR, 740393MR2, MHSPRGEMR2, 419383ARTMR, 419407MR1, 330746MR, 740455MR, 580272MR2, 580272MR, 580223AMR, 580251MR1, 580548BWB, 405329NMR, 405755MR1, 405636SMR1, 405751MR3, 918458MR3, 918458MR1, 918458MR2, 918567MR2, 918367MR, 918502MR6, 918502MR4, 918502MR5, MSF169-1-6XXYDCOS, 918502MR3, 918286MR, 918256MR, 580774WMR, 503253MR1, 503813MR1, 503513PMMR1, 503537PNMR2, 503216SVMR1, 503215PPMR1, 503215PPMR2, 503216SVMR2, 503717SSMR1, 610740MRER, 814889MRART, 570645MR1, 724772MRART, FITZMR, 484822MR, 610333MR, 717334MR1, 717632MR1, 724357MRART, 814262MR15T, 484464MR, 412622MRART, 272639MR, JCIVOYAGER, 215955MR3G, 215FCCC450W, JEFFNAVY, JEFFCOB450W1, 412835MR1, 267985MR, 610628MR, 814237MR450W, 215674OP450W, 412650MRART, 570321MR, 610988MR2, 717812MR, 864512MR1, 843402ART, 843724ART, 843847MR, 803461MRI, 803313ART, 864487UPMR, 864227MR2, 864560PMR, 803313DVMR1, 843390MR, 843606MPMR, 843416ARTIST, 843692GSART, 843832SMR, 843549ART, GON5151028, 605256MR450W, 605995MR, 605341MR1, 605322MR3, 615446ART1, 615771MRMD, 901GTOPMR1, 615338ART1, 615SMTOPMR1, 615SUMMITMR2, 615SUMMITMR, 423794MR, 865305MR, 901523ART, 901227ART, 901516ART3215, 901516ART15, 423926MR1, 423926MR2, 615769MR2W, 615SCMR2W, 512BSWSAMR, 956350MRW, 325646MR, 512BSWBUDAMR, 817517MR1, 713790MR2, 832912MR1, 281758MR355, 972566MR1, 972566MCHSMR, 214276MR1, 830VVARTMR, 940536EDMR1, 214420CDIDMR, 806935MRI450W, 915832HOPE, 915577ARTIST, 817AMERMR1, 817922ADIMR1, 972497BSFMR2, 830426MCMR, 713527MR1, 713ACB4MR24, 713442KSMR6, 713442MR1, MHMOBILEMR1, 713442KSMR5, 281333MR3, 281588MR, 713442KSMR4, 713792AMR21, 713441MR10W, 281NWARTIST, 713791VAMR1W, 512SHMRI, 806UMCWM15T, 956632ARTIST, 972540MMWMR1, 469815BCMR1, 936568HDX, 972596MCPMR2, 972596MCPMR1, 972617REDMR1, 512341MR3, 210VHSART, 936275SAMR1, 713897MWMR1, 817424ESLMR1, 713442KSMR8, 713442FTBNDMR1, 972798ESWMR1, 936271MR2, 281401MR1, 903533HDXT, 361572CICMR, 254751PMR1, 817599WRMR1, 713442CLMR1, 801756MR2, 801299MR2, 435BCMR, 801LONEMR1, 435HEBERMR1, 435635MR1, 801LAYMR2, 801LAYMR1, 435623MR2, 801MCDMR1, 801714MR1, 435PARKARTISTMR2, 801465MR2, 801373MR4, 435893MR1, 801RIVMR3, 435251MR2, 801LEHIMR1, 801588MROR, 801268MRARTIST, 801588MR01, 801SSMR, 801SPFRKMR1, 276258MRART, 703204MR1, 804CHEDMR, 434799ART, 703573ART5, 703391MR1, 703805MR2, 5101520MR81, 540SRMCMR, 703573ART8, 703858MR1, 703205MR3, 804764MR450W, 804SF450W, 703689MR, 804225MR, 804JWSPMR, 804281450W, 540776MR, 757673MRART, 802775MR, 425637VM450MR, 509765MR, 509332MR450W, 425486EVMR, 206744HMR, 360744HM450MR, 509474SH15T, 509434ART, 509473ART, 509482MR2, 715838MR1, 920288MR2, 920406HDX, 608262MR2, 608ONCMR1, 608VAARTIST, 608262MR3, 608287MR1, 715735MR1, 414805MR7, 920729ARTIST, MR1020321, 920208MR1, 715346MR1, 608372MR, SHIMR02613, SHIMR02611, SHIMR02651, 920262MR2, 414778MR1, 262429MR1, 304255VMR2, 304766MR4, 304526SMR2, DZ4953MR01, MR6033AR, MR3158AR, MR8772AR, 0910272091, 0910272093, 83195528655, 0910274042, 83202332947, 833MR000019, 83185224328, 83211314049, 833MR000035, 833MR000032, AH7084MR01, 130083MR06, 190194MR01, 190052MR01, 080026MR04, 030020MR03, 030151MR02, 080038MR01, 019022MR01, 019022MR07, 080100MR01, MRPM0227, MRPM0122, MRHM2195, BA4017MR01, MRHM2198, MRHM2005, MRHM1985, MRPM0952, MRPM0126, MRHM1900, MRR7938, MRPM0178, MRHM2122, MRPM1089, MRR10280, MRHM2039, MRHM1996, BG4042MR01, 902465MR, 905522MR1, 613632MR1, KWMRIHDXT, 604534MRART, 403382MR1, 604463MRART, 506623MR1, 506857MR2, 514934MR3, E416249MR3, 514697MR1, 905684MR1, 506648MR3, 902567MR, 250370ARTIST, 514939MR2, 514939MR1, 416756MR2, 902470MR, MRHM2116, MR2651956V2, MR6447CL, MRHM2245, MRHM2207, MRHM2249, 37448269MR, MR6746CO, DK1001MR01, DK1044MR04, DK1044MR06, DK1044MR07, DK1044MR08, DK1029MR05, DK1030MR05, DK1030MR04, DK1567MR01, DK1296MR01, MR6826DO, EG1194MR01, EG2650MR01, EG2646MR01, EE4019MR04, EE4019MR03, FI1075MR01, FI1120MR01, FI1693MR01, FI1175MR01, FI1052MR02, X121122501, M2002652, 06825989, S41600139, S4160096, M4161669, X616953011, M4409451, M4164350, M373312701, A2032125, X1478403, M4018553, M4016052, A4167357, X4479206, M4167842, M220648614, M2740512, 08607638, 07290913, F4171514, M4016577, M4020545, 05803166, 05840914, M2148263, M4490023, 05841009, X59655535, A62925713, X2007313, X629257022, M4173507, 07616398, M4174556, 06283325, M23084341, M178899204, A178899201, X1617001, X106415412, 06442791, M1425524, M4216461, 05803153, M4548544, X756087027, M4183857, X90281622, X967501009, M1656640, M24313807, H68439574, X401876904, C21952109, M4144365, 07335100, M4459621, X2181508, 07893363, M4631109, M4499039, 06889963, M5480794, A4194463, M4134656, M40330128, M4037076, M2637327, M1400959, 07809641, A9190175, M9708014, M206565705, 07307575, M54849101, 06442787, M40345203, M176430616, M5484987, M22635307, A9190184, A9502027, M54606128, M2634911, M2634913, M215517204, A1588529, M4200637, X354818502, 9913017, M178710409, M41439106, M4484752, M2322266, M1460212, M401886301, X118196008, H4858987, M4210251, M4210253, M4475682, X4211056, M2848452, 6278434, M42155110, M42155108, M42155103, X220730403, M226407304, M45052120, 9063097, 7838453, 129619MR01, HC6051MR01, 125995MR01, 351482MR01, PC7479MR10, PC8740MR02, HJJH01MR01, PC1455MR02, PC0396MR11, 123702MR01, HC7498MR03, HC3702MR01, HC1770MR03, HPAD01MR01, HC3996MR03, UC1559MR03, PC3312MR02, GON5402630, H10392MR52, H1943MR12, 0828270052IB01, 0828270065, 0828270056IB01, 0828270063, 0828270053IB01, HU1677MR01, 083027001002910, 083027004207919, 083027002227411, R83027204626924, R83027244108223, 083027060255422, 083027009119914, 083027824772621, 083027821317819, 083027202100488, 083027201013310, 083027205726822, 083027208006511, 083027206937710, 083027064149415, 083027043313421, 083027808143521, 083027847234115, 083027847898022, 083027021913318, 083027021866615, 083027000042713, IR2452MR01, MR50351941, IE1265MR01, A5127236, A5992703, A5649021, A5130628, A5165733, A5624157, A5315597, A670060237, 09509308, A258001703, A127292419, C5323541, A51529243, D5249954, A5105766, A5314615, A5401395, EM0808, EM0924, EM0930, MR00078, GON5441641, EM0921, MR00087, EM0802, EM0805, EM0814, EM0918, EM0901, MR00245, EM0917, EM0809, MR00008, EM0811, EM0803, EM0812, EM0905, EM0801, MR00088, MR00208, MR00086, EM0902, EM0807, EM0815, MR00221, MR00012, EM0800, EM0907, MR00166, MR00158, MR00217, EM0925, MR00001, MR00056, MR00005, EM0804, EM0810, EM0900, MR00237, MR00238, MR00156, EM0915, EM0926, MR00230, EM0813, MR00248, MR00037, EM0806, MR00242, EM0911, 0850270460, 0850270538, 0850270432, 0850270323, 0850270317, 0850270227, 0850270636, 0850270395, 0850270307, 0850270399, 0850270298, 0850270449, 0850270157, 0850270224, 0850270664, 0850270714, 0850270428, 0850270513, 0850270127, 0850270173, 0850270278, 0850270424, 0850270065, 0850270389, 0850270314, 0850270252, 0850270133, 0850270789, KW1013MR06, KW1013MR07, KW1013MR08, KW1013MR05, KW1001MR04, KW1008MR05, KW1008MR06, KW1008MR07, KW1002MR01, KW1007MR05, KW1007MR04, KW1006MR04, MR52660981, MR52660991, MR52661284, MR51319271, MR51319281, KW1003MR01, KW1112MR01, KW1004MR04, KW1155MR02, 080017MR02, 080017MR01, 110807MR03, 110807MR02, 030013MR05, 0834270016, MRR9771, 2884783MR, MRR11569, MRHM2073, MR52993021, MR52992811, MA1877MR01, RTD01203, RTD01202, 85114777250, 859MR000011, 85155343850, 85177987565, 859MR000025, NO1011MR02, OM1007MR02, PK1035MR01, MR8375PE, MR2323PE, MR4604787PE, 1557MR0034, PL1476MR02, PL1584MR02, PL0551MR02, PL1580MR02, PL1689MR01, PL1661MR01, PL1698MR01, PL1312MR03, PL1312MR02, 600034MR01, PL2201MR01, PL3376MR01, PL1150MR02, PL1234MR01, 600042MR03, PL1169MR02, PL3254MR01, PER08329, PPR29816, MR1730PR, MR7598PR, MR53527301, RO1079MR01, RU9571MR01, RU1156MR01, RU1095MR04, RU7984MR01, RU1128MR02, RU1128MR01, RU3509MR01, RU1296MR02, RU2275MR01, RF2817MR01, RF1383MR01, RF0929MR02, RF3309MR01, SA2706MR01, SA2633MR01, SA1039MR03, SA2308MR01, SA1209MR01, SA1012MR06, SA1034MR04, SA2643MR01, MR51994661, RS4060MR01, RS4199MR02, RS4199MR03, RS4095MR02, 6073MR0042, 6073MR0049, 6073MR0045, 6073MR0041, ZA1374MR01, DEN272171, DEN272172, NPD29701, FPG103200, MPX82200, CPZ38301, NE203172, CE270998, FEC800342, FE421194, FED03936, UE929541, DE492A102, DED647172, DE5284115, DPN89122, DE5284116, DPD15902, DED647131, DPB15881, DPN26335, DEK78891, CEG94657, MEX617112, CPZ09633, CE165375, UPW25212, FE457A208, NEV439244, NP473633, NPV22537, NP473629, CPI21217, A004MR04, A004MR06, O009MR04, M007MR01, N004MR01, M001MR01, N002MR04, 788000MR01, 492360MR01, 121351MR01, 123953MR02, 850020MR03, 0853270191, 0853270231, 0853270194, 0853270207, 0853270213, 0853270228, 0853270197, 0853270215, 0853270198, 0853270217, 0853270232, 0853270209, 0853270199, 0853270225, 0853270204, 0853270205, 1573MR0043, 0856270046, 1573MR0009, 1573MR0027, 1573MR0033, TN1059MR02, TN1166MR01, 01085MRS01, 34727MRS01, AE1485MR01, AE1367MR01, AE1626MR01, 00487MRS03, 70001MRS12, 77624MRS05, 77624MRS07, 00222MRS02, 00243MRS09, 00243MRS06, 10572MRS02, 77055MRS04, 00109MRS01, 00440MRS09, 00740MRS03, 10223MRS01, 00507MRS02, 00130MRS04, 10044MRS03, 00203MRS02, 00203MRS01, 10627MRS01, 00025MRS02, 00025MRS01, 10307MRS05, 70383MRS06, 70043MRS06, 11187MRS02, 00023MRS02, 01050MRS01, 70065MRS05, 00230MRS02, 00131MRS02, 00263MRS05, 00020MRS07, 00020MRS03, 00223MRS04, 05249MRS01, 00240MRS02, 10433MRS01, 00244MRS02, 00674MRS02, 907ULMCARTIST, MRPM1147, MRPM0735, MR4362UY, 5973MR0009, 303467MR1, 570501MR1, 11923362, 0828270037IB02, 407303MRER (w/ EVO upgrade), 214420MR1 (w/ EVO upgrade).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2469-2024

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.

Aug 22, 2025 Other Medical Devices Nationwide View Details →