CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report

Discovery MR750w Nuclear Magnetic Resonance Imaging System recalled

GE Medical Systems is recalling Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following, distributed nationwide in the US. The recall was initiated on 6 Jun 2018 and the FDA has classified it as Class II.

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Lot, batch or date codesThe following Product Name, Serial numbers and System IDs are associated with this recall. Product Name, Serial Number, (System ID); A. 3.0T MR750 32CH, N/A, (HC1627MR04); B. 3.0T MR750W, 00001134FMM10P, (0910274040); 00001117FMMOCN, (PNUE08MR01); 00001204FMM054, (083027062157412); 00001236FMM04P, (EM0271); 00001308FMM05M, (EM0272); 00001308FMM04T, (EM0229); 00001308FMM063, (EM0232); 00001236FMM00M, (EM0215); 00001234FMM0KA, (EM0221); 00001236FMM01R, (EM0214); 00001309FMM06A, (EM0245); 00001112FMM081, (EM0202); 00001227FMM00J, (EM0208); 00001250FMM01W, (EM0227); 00001308FMM012, (EM0254); 00000310839MR6, (EM0276); 00001236FMM01G, (EM0213); 00001301FMM04H, (EM0235); 00001308FMM05B, (EM0234); 00001406NMM0C7, (EM0262); 00000310905MR5, (EM0269); 00000310906MR3, (EM0273); 00001250FMM02U, (EM0228); PG75W1600020MR, (EM0295); PG75W1600036MR, (EM0301); PG75W1600013MR, (EM0291); PG75W1600025MR, (EM0293); 00001236FMM016, (EM0238); 00000310474MR2, (EM0267); 00000310702MR6, (EM0277); 00001308FMM01Y, (EM0249); 00001140FMM0FU, (EM0205); 00001236FMM05E, (EM0239); 00001147FMM0EE, (EM0222); 00001227FMM00C, (EM0225); 00000304861MR8, (EM0206); 00001221FMM0BB, (EM0210); 00001308FMM03L, (EM0248); PG75W1500006MR, (EM0286); 00000000UA0488, (EM0285); PG75W1500007MR, (EM0290); 00000310677MR0, (EM0268); 00000310475MR9, (EM0264); 00000000UA0507, (EM0284); PG75W1600006MR, (EM0289); 0000000UA0427A, (EM0282); 00001406NMM080, (EM0263); 00000310588MR9, (EM0287); 00000000UA0545, (EM0288); 00000310903MR0, (EM0274); 00000310420MR5, (EM0266); 00000310421MR3, (EM0281); 00000310720MR8, (EM0280); 00001406NMM05U, (EM0270); 00001308FMM034, (EM0253); 0000000UA0397B, (EM0283); 00001236FMM01H, (EM0241); 00001236FMM020, (EM0240); 00001308FMM022, (EM0244); 00001308FMM055, (EM0231); 00001309FMM09Y, (EM0257); 00001220FMM01J, (EM0207); 00001309FMM051, (EM0261); 00001308FMM01U, (EM0265); 00001309FMM095, (EM0275); 00001203FMM0VX, (EM0219); 00001308FMM01P, (EM0255); 00001308FMM020, (EM0256); 00001203FMMOUW, (EM0212); 00001236FMM05U, (EM0246); 00001234FMM0KH, (EM0223); 00001203FMM0V2, (EM0230); 00001309FMM08Y, (EM0243); 00001221FMM06R, (EM0220); 00001301FMM04V, (EM0233); 00001250FMM02G, (EM0226); 00001309FMM05Y, ( EM0247); 00001117FMM0CE, (EM0204); 00001250FMM02Y, (EM0236); 00000310976MR6, (EM02780); 00000000UA0468, (EM0279); 00001134FMM10L, (EM0201); 00000308133MR8, (EM0237); 00001147FMM0E8, (EM0217); 00001308FMM027, (EM0242); 00001309FMM08H, (EM0258); 00001227FMM00V, (EM0211); 00001140FMM0FL, (EM0218); 00000302811MR5, (EM0203); 00001233FMM076, (EM0250); 00001301FMM03C, (EM0260); 00001220FMM01H, (EM0209); 00000000UA0358, (EM0259); 00001236FMM00X, (EM0216); C. 3.0T MR750W GEM, PG75W1600039MR, (HC5284MR04); 00000310703MR4, (123953MR01); D. 3.0T MR750W GEM ENAB, 00001139FMM0D7, (BY4160MR01); E. 3.0T MR750W GEM ENABLED, 00000000UA0437, (DZ1060MR04); 00000310539MR2, (DZ1638MR01); 00000308883MR8, (83104203907); 301100984, (83092403928); 0000ACG3000137, (83144839290) 00000309327MR5, (83104653897); 00000309453MR9, (83108956002); 00000000UA0226, (83096535911); 00000308593MR3, (83096536248); 00000309907MR4, (83112923995); 00000309950MR4, (83112923777); 00000309051MR1, (83096322711); 00000309127MR9, (83105089955); 00001308FMM02N, (BH1017MR01); 00001219FMM0GM, (140024MR01); 00001406NMM0C0, (220826MR01); 0000310163MR01, (220826MR02); 00000000UA0482, (EG1526MR05); 00001309FMM0A6, (M4018549); 00000310538MR4, (M4172341); 00000311037MR6, (M4035023); 00001406NMM0CN, (M365865301); 00001204FMM05C, (N4192951); 00001441RG00JR, (X41944010); 00000309695MR5, (M54606125); 00001204FMM048, (M2322246); 00001204FMM05F, (M45052106); 00001204FMM05J, (PC9953MR01); 00000305145MR5, (UC2547MR01); 00001309FMM04U, (PC3003MR01); 00000302668MR9, (HC3068MR01); 00001140FMM0FF, (HU1098MR02); 00000301768MR8, (083027848548411); 00001406NMM05A, (083027244278914); 00000310060MR9, (083027246282014); 00000309951MR2, (083027861452415); 00001118FMM0WJ, (083027000049312); 00000311040MR0, (083027020204715); 00001308FMM065, (IE1010MR01); 00001203FMM0VY, (B5129925); 00000310542MR6, (KW1100MR02); 00001236FMM05A, (KW1005MR04); 00001309FMM096, (KW1019MR03); 00000301969MR2, (LB1331MR01); 00001250FMM028, (LB1160MR02); 00001301FMM04M, (LB1006MR02); 00000310773MR7, (85110163303); 00001140FMM0G4, (0920279031); 00000307192MR5, (85092252519); 00001309FMM0AE, (PL3277MR01); 00001308FMM05C, (QA1042MR010); 00001204FMM04A, (RO1098MR02); 00001307FMM08M, (RU8792MR01); 00001308FMM064, (SA1223MR01); 00001309FMM087, (SA1058MR03); 00001309FMM05E, (SA1255MR03); 00001309FMM06W, (725100MR02); 00001142FMM092, (120810MR02); 00001227FMM00N, (26001MRS01); 00001204FMM04B, (34348MRS01); 00000309908MR2, (53008MRS010); 00000000UA0097, (AE1016MR01); 00001309FMM04T, (10692MRS01); 00001309FMM07M, (77266MRS03); 00001250FMM038, (00010MRS02); 00000310424MR7, (10722MRS01); 00000310701MR8, (20312MRS01); F. 3.0T MR750W GEM ENABLED PLU, 00000000UA0526, (5973MR0007); G. 3.0T MR750W GEM ENABLED PLUS, PG75W1700001MR, (M44849103); 00000000UA0581, (M4016047); 00000000UA0531, (HU1039MR05); PG75W1600061MR, (IE1100MR02); 00000000UA0661, (MQ1000MR02); PG75W1600049MR, (NO1012MR02); PG75W1600001MR, (A202MR02); H. 3.0T MR750W W GEM, 00001134FMM10K, (M4166994); 00000000UA0016, (X59007321); 00001135FMM019, (SA1033MR01); 00000000UA0023, (0847270026); 00001134FMM10D, (A010MR08); 00001250FMM039, (387040MR10); 00000000UA0049, (850020MR02); 00001111FMM0B7, (70431MRS04); I. 3.0T MR750W WITH GEM, 00000310953MR5, (A1765918); 00001236FMM05D, (HC0220MR03); J. 3-0T MR750 32 CHANNEL, 00000000UA0071, (585275MR750W); K. 3-0T MR750W FUTURE GEM CAPABLE, 00000000UA0083, (408356MR1); 00001140FMM0FG, (407SMSLMR1); 00001147FMM0E5, (386FHPCMR3T); 1-4GFG-928, (319335MR2); 1236FMM04H, (337943MR1); Missing_SN_GON4216878, (240707MR3T); 00001309FMM084, (441239MR750W); 00001221FMM06K, (083027840038612); L. 3-0T MR750W GEM, 826, (9157473TMR); 00000000UA0304, (210AMVAMR); UA0720, (7182005MR); M. 3-0T MR750W GEM ENABLED, 00001250FMM03D, (9075653T); 00001308FMM00B, (602863MR); Missing_SN_GON4205067, (480342MR3); 00001134FMM10E, (928348MR); 00001140FMM0FX, (RADNETMR597); ACFA000788, (530CHI750W); 00000000UA0497, (858824MR1); 00001204FMM058, (RADNETMR599); 00000000UA0262, (949760MR3); 00000308185MR8, (510449MR750W); 00000000UA0075, (619543HDMR4); 00000000UA0118, (858622HDMR1); 00001204FMM052, (415CB3TW); 00001307FMM09Y, (415UCBHMR3); 00001309FMM08B, (RADNETMR613); 1-4G33-86, (805739MR3); 310871MR9, (310264MR2); UA0706, (805434MR3); 309905MR8, (RADNETMR621); 00001204FMM04G, (559734VIMR1); 000005373011-3, (RADNETMR598); 421, (720848MR4); UA0401, (720848MR3); 311108MR5, (303492MR); 00001118FMM0WE, (303604MR2); 00001309FMM09E, (720854MR); 00000000UA0472, (719365MR); Missing_SN_GON4077136, (303837MR2); 309815MR9, (970624MR1); 310950MR1, (860446MR750W); 00001251FMM00R, (202966MR3TW); Missing_sn_gon4374837, (302430MR750W); Missing_SN_GON4231312, (561955MR1); 00001309FMM097, (386FNSBMR3T); 00001308FMM042, (954355MR750W); 1309FMM09F, (904483MR3T); 00001204FMM057, (305461MR1); 00000000UA0465, (305665MR750W); 00001223FMM08M, (561844MR1); UA0704, (706787750DV); 00001236FMM04Y, (912819MR); 0000000UA0032A, (808485MR2); 310330MR6, (808HRAEMR750W); 00001204FMM055, (808545MR); 00000306104MR1, (808873MR750W); 310776MR0, (773665SJMR2); PG75W1600028MR, (312702PMR); 00001250FMM02E, (217876DMH3T); UA0441, (847316MR3T); 00000305089MR5, (708346MR3); 00000307816MR9, (708346MR4); 310973MR3, (309655IMRI); 00001309FMM094, (309655MR750W); 00001203FMM0VP, (815395MR2); UA0477, (815968MR); 00000306062MR1, (847872ZMR2); 00000309665MR8, (317887MR3); 00001308FMM03T, (317865MR4); 00001308FMM006, (913322MISHMRW); 310253MR0, (859334MR); 00001221FMM06J, (270798MR2); 1406NMM0C2, (318443MR2); 00000307418MR4, (225763MR2); 00001236FMM051, (337289MR1); PG75W1500010MR, (504VAMR3); 00001227FMM011, (BOSTONMEDMR1); 00001251FMM01F, (BRIGHAM750WMR1); MISSING_SN_GON#4350388, (508746MR3); 00001250FMM03C, (VAWESTROX750W); 00001309FMM085, (410328MR3T); 00000306342MR7, (RADNETMR1651); 00001204FMM04U, (RADNETMR1652); 00001203FMM0W2, (RADNETMR1635); 00000303329MR7, (RADNETMR1629); PG75W1600037MR, (RADNETMR6066); 223355, (3014643TMR); 00001301FMM047, (301570MR); 00000000UA0301, (RADNETMR1662); Missing_SN_GON4373937, (RADNETMR6073); UA0601, (RADNETMR6071); 310719MR0, (RADNETMR1686); 00001308FMM046, (207MMC3TMR); 130FMM07E, (734845VA750MR); 1442RG01YE, (248533750W); 00001134FMM10U, (616774MR750W); 00001227FMM00W, (616267IMRI); 00001308FMM01H, (763795MR1); 00000306613MR1, (MR229047); 00001250FMM01U, (MR229046); 00001308FMM007, (MR229048); UA0368, (MR229050); Missing SN, (MR229054); 00000000UA0091, (314577CGMR3T); 00001233FMM06K, (6033343TW); 00001204FMM04E, (RADNETMR1631); 00001203FMM0UK, (RADNETMR1632); 311106MR9, (856537MR); 00000304496MR3, (856247MR3); 00001233FMM06X, (856247MR1); 00001227FMM00T, (201445750W); 911001, (775882GBIMR); 00001308FMM02E, (702382MR750W); 00001309FMM065, (702731MR750W); 310333MR0, (RADNETMR1687); 00000122FMM015, (RADNETMR1648); 00001134FMM10R, (71872MR750W); UA0315A, (516NS7113T); 00001309FMM07F, (914750W); 00001203FMM0VB, (EAST750W); PG75W1600021MR, (MSK68MR03); 00001140FMM0FT, (21277MR1); 00001236FMM04X, (COR526967); 00001308FMM008, (MSK68MR7); 00000000UA0363, (MSK53MR02); UA0418, (212288MR4); 00000308347MR4, (MSK68MR1); 1406NMM058, (716740MR1); 00000305184MR4, (RADNETMR1639) PG75W1600043MR, (585266MR3T); 00001308FMM02T, (718226MR3T); 00000305090MR3, (330344MR750W); 00001308FMM02C, (513636MR4); 309752MR4, (614293MR9); 00001111FMM0B2, (61456MR5); 00001309FMM09G, (6142343T); 00001111FMM0AY, (614GMC3T); 00001250FMM02H, (937641MR2); 00000000UA0405, (937208MR1); 00001142FMM08Y, (405271OUCMR); 1059, (405636SMR2); 1307FMM088, (503251PMR3); 1406NMM0C5, (412914MR); 00001308FMM032, (PRESBYMR1); UA0627, (215728MR3T); 00001308FMM028, (843815750W); 00000306781MR6, (843750WGEM); 00000306801MR2, (864529MR); 309780MR5, (423493MR750W); 00001309FMM047, (865984MR750); 309948MR8, (817433HSWMR2); 310952MR7, (512544SD3T); 00001250FMM02W, (214645UT3TMR1); 00001308FMM02A, (2148203TMR); 311364MR4, (409772MR6); PG75W1600019MR, (713792AMR16); 00001308FMM05P, (713798MR1); 00000000UA0396, (713792AMR14); PG75W1600038MR, (713799TOMR1); PG75W1600078MR, (713792AMR18); 00000000UA0457, (903236MR750W); PG75W1600011MR, (713363MR750); 00001251FMM01E, (210617HUBMR); UA0419A, (210WHASCMR1); 00001134FMM10C, (281274MR2); 00000000UA0416, (903525MR750W); 00001204FMM04Y, (435251MR1); PG75W1500005MR, (434MJMR2); 00001307FMM089, (703573MR1DV); 00000000UA0124, (703698MR4); 00000304862MR6, (757827MR2); 00001309FMM0AF, (703478MR2DV); 00000000UA0141, (757983MR); 310775MR2, (206781SB750W); 00001221FMM06M, (206292SR750W);; ACF8000466, (206320CH750W); 1307FMM086, (920738MR750); 00001250FMM02N, (608775MR3T); 310777MR8, (608VAMR750W); 00001251FMM012, (608263MR5W); 00001309FMM07N, (608CHILDMR1); 00001250FMM03A, (414647MR1); UA0523, (414649WB2); 00001309FMM05F, (715847MR3T); Missing_SN_GON4216470, (307BHBBJ3T); 00001203FMM0VW, (0910273043); 00000309423MR2, (AP7645MR01); 00001233FMM06W, (130083MR05); 00001308FMM02R, (220078MR01); 00000000UA0467, (MRUA0467); 00000310904MR8, (MRUA0394A); PG75W1600012MR, (MRUA0566); 00001406NMM00K, (BG4680MR01); 663, (506648MR4); 00000000UA0364, (E416249MR2); 00001134FMM104, (613737MR1); 00000303954MR2, (M9481853); 00001307FMM08H, (TP4447MR02); 00001301FMM043, (671NAVYMR); 00001234FMM0KL, (671FHPMR750W); 00000309164MR2, (083027860052014); 00001236FMM05Y, (083027200034313); 00001250FMM01T, (083027000013713); 00000310162MR3, (A5547422); 00001309FMM05G, (A5360437); 00001301FMM03X, (A5111746); 00001309FMM07R, (B5174327); 00001309FMM0AJ, (A5719869); 00001406NMM02J, (KA1023MR02); 00001308FMM02P, (MR308183MR3); 00000304860MR0, (RTD0191); 00001147FMM0E6, (UDN0121); 00001308FMM05H, (PL3116MR01); 00001250FMM02P, (600042MR02); 00000000UA0480, (PL3554MR01); 00000310304MR1, (RU1111MR02); 00001406NMM01E, (RU1717MR01); 00000000UA0227, (RU8438MR01); 00000000UA0229, (RU8438MR03); 00001234FMM0KG, (RU5599MR01); 00001308FMM03B, (RU8615MR01); 00001406NMM02X, (RU8937MR01); 00001307FMM07X, (6073MR0003); 00000306101MR7, (M001MR02); 00001309FMM076, (C001MR01); 00001309FMM05J, (N002MR03); 00000310540MR0, (259130MR12); 00001309FMM05N, (150250MR01); 0000000UA0430A, (568987MR01); 00000310604MR4, (0856270071); 00001309FMM07G, (06162MRS01); PG75W1600005MR, (AE1546MR01); 00000000UA0265, (00230MRS01); 00001406NMM09X, (MRUA0353); N. 3-0T MR750W GEM ENABLED PLUS; PG75W1600058MR, (904202MR12); PG75W1600017MR, (312702MR750); PG75W1600054MR, (630833ELM3T); 00000007T5MV12, (336832MR750); N/A, (732MSKMR); PG75W1600045MR, (MNMR01); 310949MR3, (631623MR750); Missing_SN_GON4292927, (914631MR); 310902MR2, (215829MR750W); PG75W1500001MR, (703698MR5); N/A, (206223VM750W); 00000310697MR8, (608265MR750W); O. 3-0T MR750W NON GEM, 00001251FMM01C, (856581MR3T); 00001301FMM03E, (MRUA0122); P. 3T 750W, 0000000JWB0DZ1, (0850270459); 00001309FMM04W, (0850270446); 00001204FMM04V, (0850270386); 00000306791MR5, (0850270430); 00001250FMM03E, (0850270426); 00000000UA0170, (0850270427); 00001309FMM055, (0850270455); 00000000UA0483, (0850270478); 00000308159MR3, (850270436); 00001221FMM06X, (0850270409); 00001233FMM06M, (0850270414); 00000311338MR8, (0850270481); 00001227FMM00X, (0850270411); Q. DISCOVERY MR 750W 3.0T, 00000309092MR5, (MRUA0272); 00001308FMM048, (0853270141); PG75W1600052MR, (0853270159); R. DISCOVERY MR750W, 00001251FMM014, (O009MR03); 00001251FMM00J, (M004MR01); 00001236FMM04T, (T002MR01); S. DISCOVERY MR750W 3, 00001441RG00L1, (082427200086); 00001442RG01XE, (082427160158); 00001437RG01DK, (082427160160); 00001442RG01XC, (082427180035); 00000309522MR1, (082427160149); 00001442RG01Y0, (082427170020); 00001442RG01XK, (082427070157); 00001438RG00KT, (082427070164); 0000309837MR3, (082427010087); 00001438RG00L1, (082427210149); 00001438RG00L6, (082427120159), 00001437RG01DM, (082427120149); 00001438RG00LB, (082427120168); 00001406NMM0BP, (082427120136), 00001406NMM05T, (082427040173); 00001438RG00KP, (082427040197); 00001438RG00KR, (082427040195); 00001438RG00LA, (082427040190); 00001442RG01XL, (082427040179); 00001442RG01Y9, (082427040167); 00001308FMM035, (082427160127); 00001406NMM09V, (082427110051); 00001406NMM0BE, (082427120131); 00001309FMM0A8, (082427100225); 00001406NMM0BJ, (082427180028); 00001406NMM0B7, (082427130076); 00001442RG01YR, (082427120135); 00001442RG01Y4, (082427100267); 00001438RG00L3, (082427100265); 00001442RG01YK, (082427100254); 00001444RG028E, (082427100271); 00001442RG01YJ, (082427100246); 00001438RG00L2, (082427250056); 00001438RG00LG, (082427140124); T. DISCOVERY MR750W 3T, 00001437RG01DD, (082427040139); 00001441RG00KT, (082427010080); 00000305814MR6, (082427210118); 00001442RG01YT, (082427210129); 00001236FMM01N, (082427210109); 00000306638MR8, (082427120116); 00001406NMM082, (082427120122); 00000307589MR2, (082427120124); 00000307210MR5, (082427120110); 00000306350MR0, (082427040135); 00000306700MR6, (082427040146); 00001442RG01Y1, (082427040194); 00000309521MR3, (082427060052); 00000307568MR6, (082427100219); 00001438RG00KM, (082427140133); U. DISCOVERY MR750W GEM, 00000306902MR8, (083027200005613); 00000000UA0493, (LV4032MR01); V. DISCOVERY MR750W WITH GEM, 00001142FMM090, (10639MRS01); 00001142FMM094, (10678MRS01); W. MR 3.0T MR750 W, 00000000UA0082, (DPN26332); X. MR 3.0T MR750W GEM ENABLED, 00001142FMM096, (MPX94401); 00000000UA0425, (DPN36500); Y. MR 3-0T MR750W, 00001309FMM08R , (UE929526); Z. . MR DISCOVERY 750W GEM, 00001117FMM0CP, (PC9595MR01); AA. MR OPTIMA MR750W 3.0T, 00001234FMM0KB, (MRUA0136); BB. MR750W, 00001309FMM072, (MRUA0191); CC. MR750W GEM ENABLED, 00001203FMM0V5, (0835270026); PG75W1600003MR, (ZA2812MR01); DD. MR750W GEM ENABLED PLUS, 00000000UA0486, (00440MRS08); EE. MR750W PGR 32-CHANNEL, 00001309FMM08P, (MRUA0343); FF. 3.0T MR750W GEM ENAB, 00001139FMM0D7, (BY4160MR01)

Quantity recalled516 Units Total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3279-2018
FDA event ID: 80264
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2018
FDA classified: 27 Sep 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

6 Jun 2018	Recall initiated by company
27 Sep 2018	Classified by FDA	+113 days
3 Oct 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.

Product as listed by the FDA

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..

Where it was distributed

Worldwide Distribution - US Nationwide and in the states of AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, UT, VA, WA, WI, and WY. and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, China, Egypt, France, Germany, Guam, Hungary, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, (Republic of), Kuwait, Latvia, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

Nationwide Alaska Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Why was it recalled?

Which lots are affected?

The following Product Name, Serial numbers and System IDs are associated with this recall. Product Name, Serial Number, (System ID); A. 3.0T MR750 32CH, N/A, (HC1627MR04); B. 3.0T MR750W, 00001134FMM10P, (0910274040); 00001117FMMOCN, (PNUE08MR01); 00001204FMM054, (083027062157412); 00001236FMM04P, (EM0271); 00001308FMM05M, (EM0272); 00001308FMM04T, (EM0229); 00001308FMM063, (EM0232); 00001236FMM00M, (EM0215); 00001234FMM0KA, (EM0221); 00001236FMM01R, (EM0214); 00001309FMM06A, (EM0245); 00001112FMM081, (EM0202); 00001227FMM00J, (EM0208); 00001250FMM01W, (EM0227); 00001308FMM012, (EM0254); 00000310839MR6, (EM0276); 00001236FMM01G, (EM0213); 00001301FMM04H, (EM0235); 00001308FMM05B, (EM0234); 00001406NMM0C7, (EM0262); 00000310905MR5, (EM0269); 00000310906MR3, (EM0273); 00001250FMM02U, (EM0228); PG75W1600020MR, (EM0295); PG75W1600036MR, (EM0301); PG75W1600013MR, (EM0291); PG75W1600025MR, (EM0293); 00001236FMM016, (EM0238); 00000310474MR2, (EM0267); 00000310702MR6, (EM0277); 00001308FMM01Y, (EM0249); 00001140FMM0FU, (EM0205); 00001236FMM05E, (EM0239); 00001147FMM0EE, (EM0222); 00001227FMM00C, (EM0225); 00000304861MR8, (EM0206); 00001221FMM0BB, (EM0210); 00001308FMM03L, (EM0248); PG75W1500006MR, (EM0286); 00000000UA0488, (EM0285); PG75W1500007MR, (EM0290); 00000310677MR0, (EM0268); 00000310475MR9, (EM0264); 00000000UA0507, (EM0284); PG75W1600006MR, (EM0289); 0000000UA0427A, (EM0282); 00001406NMM080, (EM0263); 00000310588MR9, (EM0287); 00000000UA0545, (EM0288); 00000310903MR0, (EM0274); 00000310420MR5, (EM0266); 00000310421MR3, (EM0281); 00000310720MR8, (EM0280); 00001406NMM05U, (EM0270); 00001308FMM034, (EM0253); 0000000UA0397B, (EM0283); 00001236FMM01H, (EM0241); 00001236FMM020, (EM0240); 00001308FMM022, (EM0244); 00001308FMM055, (EM0231); 00001309FMM09Y, (EM0257); 00001220FMM01J, (EM0207); 00001309FMM051, (EM0261); 00001308FMM01U, (EM0265); 00001309FMM095, (EM0275); 00001203FMM0VX, (EM0219); 00001308FMM01P, (EM0255); 00001308FMM020, (EM0256); 00001203FMMOUW, (EM0212); 00001236FMM05U, (EM0246); 00001234FMM0KH, (EM0223); 00001203FMM0V2, (EM0230); 00001309FMM08Y, (EM0243); 00001221FMM06R, (EM0220); 00001301FMM04V, (EM0233); 00001250FMM02G, (EM0226); 00001309FMM05Y, ( EM0247); 00001117FMM0CE, (EM0204); 00001250FMM02Y, (EM0236); 00000310976MR6, (EM02780); 00000000UA0468, (EM0279); 00001134FMM10L, (EM0201); 00000308133MR8, (EM0237); 00001147FMM0E8, (EM0217); 00001308FMM027, (EM0242); 00001309FMM08H, (EM0258); 00001227FMM00V, (EM0211); 00001140FMM0FL, (EM0218); 00000302811MR5, (EM0203); 00001233FMM076, (EM0250); 00001301FMM03C, (EM0260); 00001220FMM01H, (EM0209); 00000000UA0358, (EM0259); 00001236FMM00X, (EM0216); C. 3.0T MR750W GEM, PG75W1600039MR, (HC5284MR04); 00000310703MR4, (123953MR01); D. 3.0T MR750W GEM ENAB, 00001139FMM0D7, (BY4160MR01); E. 3.0T MR750W GEM ENABLED, 00000000UA0437, (DZ1060MR04); 00000310539MR2, (DZ1638MR01); 00000308883MR8, (83104203907); 301100984, (83092403928); 0000ACG3000137, (83144839290) 00000309327MR5, (83104653897); 00000309453MR9, (83108956002); 00000000UA0226, (83096535911); 00000308593MR3, (83096536248); 00000309907MR4, (83112923995); 00000309950MR4, (83112923777); 00000309051MR1, (83096322711); 00000309127MR9, (83105089955); 00001308FMM02N, (BH1017MR01); 00001219FMM0GM, (140024MR01); 00001406NMM0C0, (220826MR01); 0000310163MR01, (220826MR02); 00000000UA0482, (EG1526MR05); 00001309FMM0A6, (M4018549); 00000310538MR4, (M4172341); 00000311037MR6, (M4035023); 00001406NMM0CN, (M365865301); 00001204FMM05C, (N4192951); 00001441RG00JR, (X41944010); 00000309695MR5, (M54606125); 00001204FMM048, (M2322246); 00001204FMM05F, (M45052106); 00001204FMM05J, (PC9953MR01); 00000305145MR5, (UC2547MR01); 00001309FMM04U, (PC3003MR01); 00000302668MR9, (HC3068MR01); 00001140FMM0FF, (HU1098MR02); 00000301768MR8, (083027848548411); 00001406NMM05A, (083027244278914); 00000310060MR9, (083027246282014); 00000309951MR2, (083027861452415); 00001118FMM0WJ, (083027000049312); 00000311040MR0, (083027020204715); 00001308FMM065, (IE1010MR01); 00001203FMM0VY, (B5129925); 00000310542MR6, (KW1100MR02); 00001236FMM05A, (KW1005MR04); 00001309FMM096, (KW1019MR03); 00000301969MR2, (LB1331MR01); 00001250FMM028, (LB1160MR02); 00001301FMM04M, (LB1006MR02); 00000310773MR7, (85110163303); 00001140FMM0G4, (0920279031); 00000307192MR5, (85092252519); 00001309FMM0AE, (PL3277MR01); 00001308FMM05C, (QA1042MR010); 00001204FMM04A, (RO1098MR02); 00001307FMM08M, (RU8792MR01); 00001308FMM064, (SA1223MR01); 00001309FMM087, (SA1058MR03); 00001309FMM05E, (SA1255MR03); 00001309FMM06W, (725100MR02); 00001142FMM092, (120810MR02); 00001227FMM00N, (26001MRS01); 00001204FMM04B, (34348MRS01); 00000309908MR2, (53008MRS010); 00000000UA0097, (AE1016MR01); 00001309FMM04T, (10692MRS01); 00001309FMM07M, (77266MRS03); 00001250FMM038, (00010MRS02); 00000310424MR7, (10722MRS01); 00000310701MR8, (20312MRS01); F. 3.0T MR750W GEM ENABLED PLU, 00000000UA0526, (5973MR0007); G. 3.0T MR750W GEM ENABLED PLUS, PG75W1700001MR, (M44849103); 00000000UA0581, (M4016047); 00000000UA0531, (HU1039MR05); PG75W1600061MR, (IE1100MR02); 00000000UA0661, (MQ1000MR02); PG75W1600049MR, (NO1012MR02); PG75W1600001MR, (A202MR02); H. 3.0T MR750W W GEM, 00001134FMM10K, (M4166994); 00000000UA0016, (X59007321); 00001135FMM019, (SA1033MR01); 00000000UA0023, (0847270026); 00001134FMM10D, (A010MR08); 00001250FMM039, (387040MR10); 00000000UA0049, (850020MR02); 00001111FMM0B7, (70431MRS04); I. 3.0T MR750W WITH GEM, 00000310953MR5, (A1765918); 00001236FMM05D, (HC0220MR03); J. 3-0T MR750 32 CHANNEL, 00000000UA0071, (585275MR750W); K. 3-0T MR750W FUTURE GEM CAPABLE, 00000000UA0083, (408356MR1); 00001140FMM0FG, (407SMSLMR1); 00001147FMM0E5, (386FHPCMR3T); 1-4GFG-928, (319335MR2); 1236FMM04H, (337943MR1); Missing_SN_GON4216878, (240707MR3T); 00001309FMM084, (441239MR750W); 00001221FMM06K, (083027840038612); L. 3-0T MR750W GEM, 826, (9157473TMR); 00000000UA0304, (210AMVAMR); UA0720, (7182005MR); M. 3-0T MR750W GEM ENABLED, 00001250FMM03D, (9075653T); 00001308FMM00B, (602863MR); Missing_SN_GON4205067, (480342MR3); 00001134FMM10E, (928348MR); 00001140FMM0FX, (RADNETMR597); ACFA000788, (530CHI750W); 00000000UA0497, (858824MR1); 00001204FMM058, (RADNETMR599); 00000000UA0262, (949760MR3); 00000308185MR8, (510449MR750W); 00000000UA0075, (619543HDMR4); 00000000UA0118, (858622HDMR1); 00001204FMM052, (415CB3TW); 00001307FMM09Y, (415UCBHMR3); 00001309FMM08B, (RADNETMR613); 1-4G33-86, (805739MR3); 310871MR9, (310264MR2); UA0706, (805434MR3); 309905MR8, (RADNETMR621); 00001204FMM04G, (559734VIMR1); 000005373011-3, (RADNETMR598); 421, (720848MR4); UA0401, (720848MR3); 311108MR5, (303492MR); 00001118FMM0WE, (303604MR2); 00001309FMM09E, (720854MR); 00000000UA0472, (719365MR); Missing_SN_GON4077136, (303837MR2); 309815MR9, (970624MR1); 310950MR1, (860446MR750W); 00001251FMM00R, (202966MR3TW); Missing_sn_gon4374837, (302430MR750W); Missing_SN_GON4231312, (561955MR1); 00001309FMM097, (386FNSBMR3T); 00001308FMM042, (954355MR750W); 1309FMM09F, (904483MR3T); 00001204FMM057, (305461MR1); 00000000UA0465, (305665MR750W); 00001223FMM08M, (561844MR1); UA0704, (706787750DV); 00001236FMM04Y, (912819MR); 0000000UA0032A, (808485MR2); 310330MR6, (808HRAEMR750W); 00001204FMM055, (808545MR); 00000306104MR1, (808873MR750W); 310776MR0, (773665SJMR2); PG75W1600028MR, (312702PMR); 00001250FMM02E, (217876DMH3T); UA0441, (847316MR3T); 00000305089MR5, (708346MR3); 00000307816MR9, (708346MR4); 310973MR3, (309655IMRI); 00001309FMM094, (309655MR750W); 00001203FMM0VP, (815395MR2); UA0477, (815968MR); 00000306062MR1, (847872ZMR2); 00000309665MR8, (317887MR3); 00001308FMM03T, (317865MR4); 00001308FMM006, (913322MISHMRW); 310253MR0, (859334MR); 00001221FMM06J, (270798MR2); 1406NMM0C2, (318443MR2); 00000307418MR4, (225763MR2); 00001236FMM051, (337289MR1); PG75W1500010MR, (504VAMR3); 00001227FMM011, (BOSTONMEDMR1); 00001251FMM01F, (BRIGHAM750WMR1); MISSING_SN_GON#4350388, (508746MR3); 00001250FMM03C, (VAWESTROX750W); 00001309FMM085, (410328MR3T); 00000306342MR7, (RADNETMR1651); 00001204FMM04U, (RADNETMR1652); 00001203FMM0W2, (RADNETMR1635); 00000303329MR7, (RADNETMR1629); PG75W1600037MR, (RADNETMR6066); 223355, (3014643TMR); 00001301FMM047, (301570MR); 00000000UA0301, (RADNETMR1662); Missing_SN_GON4373937, (RADNETMR6073); UA0601, (RADNETMR6071); 310719MR0, (RADNETMR1686); 00001308FMM046, (207MMC3TMR); 130FMM07E, (734845VA750MR); 1442RG01YE, (248533750W); 00001134FMM10U, (616774MR750W); 00001227FMM00W, (616267IMRI); 00001308FMM01H, (763795MR1); 00000306613MR1, (MR229047); 00001250FMM01U, (MR229046); 00001308FMM007, (MR229048); UA0368, (MR229050); Missing SN, (MR229054); 00000000UA0091, (314577CGMR3T); 00001233FMM06K, (6033343TW); 00001204FMM04E, (RADNETMR1631); 00001203FMM0UK, (RADNETMR1632); 311106MR9, (856537MR); 00000304496MR3, (856247MR3); 00001233FMM06X, (856247MR1); 00001227FMM00T, (201445750W); 911001, (775882GBIMR); 00001308FMM02E, (702382MR750W); 00001309FMM065, (702731MR750W); 310333MR0, (RADNETMR1687); 00000122FMM015, (RADNETMR1648); 00001134FMM10R, (71872MR750W); UA0315A, (516NS7113T); 00001309FMM07F, (914750W); 00001203FMM0VB, (EAST750W); PG75W1600021MR, (MSK68MR03); 00001140FMM0FT, (21277MR1); 00001236FMM04X, (COR526967); 00001308FMM008, (MSK68MR7); 00000000UA0363, (MSK53MR02); UA0418, (212288MR4); 00000308347MR4, (MSK68MR1); 1406NMM058, (716740MR1); 00000305184MR4, (RADNETMR1639) PG75W1600043MR, (585266MR3T); 00001308FMM02T, (718226MR3T); 00000305090MR3, (330344MR750W); 00001308FMM02C, (513636MR4); 309752MR4, (614293MR9); 00001111FMM0B2, (61456MR5); 00001309FMM09G, (6142343T); 00001111FMM0AY, (614GMC3T); 00001250FMM02H, (937641MR2); 00000000UA0405, (937208MR1); 00001142FMM08Y, (405271OUCMR); 1059, (405636SMR2); 1307FMM088, (503251PMR3); 1406NMM0C5, (412914MR); 00001308FMM032, (PRESBYMR1); UA0627, (215728MR3T); 00001308FMM028, (843815750W); 00000306781MR6, (843750WGEM); 00000306801MR2, (864529MR); 309780MR5, (423493MR750W); 00001309FMM047, (865984MR750); 309948MR8, (817433HSWMR2); 310952MR7, (512544SD3T); 00001250FMM02W, (214645UT3TMR1); 00001308FMM02A, (2148203TMR); 311364MR4, (409772MR6); PG75W1600019MR, (713792AMR16); 00001308FMM05P, (713798MR1); 00000000UA0396, (713792AMR14); PG75W1600038MR, (713799TOMR1); PG75W1600078MR, (713792AMR18); 00000000UA0457, (903236MR750W); PG75W1600011MR, (713363MR750); 00001251FMM01E, (210617HUBMR); UA0419A, (210WHASCMR1); 00001134FMM10C, (281274MR2); 00000000UA0416, (903525MR750W); 00001204FMM04Y, (435251MR1); PG75W1500005MR, (434MJMR2); 00001307FMM089, (703573MR1DV); 00000000UA0124, (703698MR4); 00000304862MR6, (757827MR2); 00001309FMM0AF, (703478MR2DV); 00000000UA0141, (757983MR); 310775MR2, (206781SB750W); 00001221FMM06M, (206292SR750W);; ACF8000466, (206320CH750W); 1307FMM086, (920738MR750); 00001250FMM02N, (608775MR3T); 310777MR8, (608VAMR750W); 00001251FMM012, (608263MR5W); 00001309FMM07N, (608CHILDMR1); 00001250FMM03A, (414647MR1); UA0523, (414649WB2); 00001309FMM05F, (715847MR3T); Missing_SN_GON4216470, (307BHBBJ3T); 00001203FMM0VW, (0910273043); 00000309423MR2, (AP7645MR01); 00001233FMM06W, (130083MR05); 00001308FMM02R, (220078MR01); 00000000UA0467, (MRUA0467); 00000310904MR8, (MRUA0394A); PG75W1600012MR, (MRUA0566); 00001406NMM00K, (BG4680MR01); 663, (506648MR4); 00000000UA0364, (E416249MR2); 00001134FMM104, (613737MR1); 00000303954MR2, (M9481853); 00001307FMM08H, (TP4447MR02); 00001301FMM043, (671NAVYMR); 00001234FMM0KL, (671FHPMR750W); 00000309164MR2, (083027860052014); 00001236FMM05Y, (083027200034313); 00001250FMM01T, (083027000013713); 00000310162MR3, (A5547422); 00001309FMM05G, (A5360437); 00001301FMM03X, (A5111746); 00001309FMM07R, (B5174327); 00001309FMM0AJ, (A5719869); 00001406NMM02J, (KA1023MR02); 00001308FMM02P, (MR308183MR3); 00000304860MR0, (RTD0191); 00001147FMM0E6, (UDN0121); 00001308FMM05H, (PL3116MR01); 00001250FMM02P, (600042MR02); 00000000UA0480, (PL3554MR01); 00000310304MR1, (RU1111MR02); 00001406NMM01E, (RU1717MR01); 00000000UA0227, (RU8438MR01); 00000000UA0229, (RU8438MR03); 00001234FMM0KG, (RU5599MR01); 00001308FMM03B, (RU8615MR01); 00001406NMM02X, (RU8937MR01); 00001307FMM07X, (6073MR0003); 00000306101MR7, (M001MR02); 00001309FMM076, (C001MR01); 00001309FMM05J, (N002MR03); 00000310540MR0, (259130MR12); 00001309FMM05N, (150250MR01); 0000000UA0430A, (568987MR01); 00000310604MR4, (0856270071); 00001309FMM07G, (06162MRS01); PG75W1600005MR, (AE1546MR01); 00000000UA0265, (00230MRS01); 00001406NMM09X, (MRUA0353); N. 3-0T MR750W GEM ENABLED PLUS; PG75W1600058MR, (904202MR12); PG75W1600017MR, (312702MR750); PG75W1600054MR, (630833ELM3T); 00000007T5MV12, (336832MR750); N/A, (732MSKMR); PG75W1600045MR, (MNMR01); 310949MR3, (631623MR750); Missing_SN_GON4292927, (914631MR); 310902MR2, (215829MR750W); PG75W1500001MR, (703698MR5); N/A, (206223VM750W); 00000310697MR8, (608265MR750W); O. 3-0T MR750W NON GEM, 00001251FMM01C, (856581MR3T); 00001301FMM03E, (MRUA0122); P. 3T 750W, 0000000JWB0DZ1, (0850270459); 00001309FMM04W, (0850270446); 00001204FMM04V, (0850270386); 00000306791MR5, (0850270430); 00001250FMM03E, (0850270426); 00000000UA0170, (0850270427); 00001309FMM055, (0850270455); 00000000UA0483, (0850270478); 00000308159MR3, (850270436); 00001221FMM06X, (0850270409); 00001233FMM06M, (0850270414); 00000311338MR8, (0850270481); 00001227FMM00X, (0850270411); Q. DISCOVERY MR 750W 3.0T, 00000309092MR5, (MRUA0272); 00001308FMM048, (0853270141); PG75W1600052MR, (0853270159); R. DISCOVERY MR750W, 00001251FMM014, (O009MR03); 00001251FMM00J, (M004MR01); 00001236FMM04T, (T002MR01); S. DISCOVERY MR750W 3, 00001441RG00L1, (082427200086); 00001442RG01XE, (082427160158); 00001437RG01DK, (082427160160); 00001442RG01XC, (082427180035); 00000309522MR1, (082427160149); 00001442RG01Y0, (082427170020); 00001442RG01XK, (082427070157); 00001438RG00KT, (082427070164); 0000309837MR3, (082427010087); 00001438RG00L1, (082427210149); 00001438RG00L6, (082427120159), 00001437RG01DM, (082427120149); 00001438RG00LB, (082427120168); 00001406NMM0BP, (082427120136), 00001406NMM05T, (082427040173); 00001438RG00KP, (082427040197); 00001438RG00KR, (082427040195); 00001438RG00LA, (082427040190); 00001442RG01XL, (082427040179); 00001442RG01Y9, (082427040167); 00001308FMM035, (082427160127); 00001406NMM09V, (082427110051); 00001406NMM0BE, (082427120131); 00001309FMM0A8, (082427100225); 00001406NMM0BJ, (082427180028); 00001406NMM0B7, (082427130076); 00001442RG01YR, (082427120135); 00001442RG01Y4, (082427100267); 00001438RG00L3, (082427100265); 00001442RG01YK, (082427100254); 00001444RG028E, (082427100271); 00001442RG01YJ, (082427100246); 00001438RG00L2, (082427250056); 00001438RG00LG, (082427140124); T. DISCOVERY MR750W 3T, 00001437RG01DD, (082427040139); 00001441RG00KT, (082427010080); 00000305814MR6, (082427210118); 00001442RG01YT, (082427210129); 00001236FMM01N, (082427210109); 00000306638MR8, (082427120116); 00001406NMM082, (082427120122); 00000307589MR2, (082427120124); 00000307210MR5, (082427120110); 00000306350MR0, (082427040135); 00000306700MR6, (082427040146); 00001442RG01Y1, (082427040194); 00000309521MR3, (082427060052); 00000307568MR6, (082427100219); 00001438RG00KM, (082427140133); U. DISCOVERY MR750W GEM, 00000306902MR8, (083027200005613); 00000000UA0493, (LV4032MR01); V. DISCOVERY MR750W WITH GEM, 00001142FMM090, (10639MRS01); 00001142FMM094, (10678MRS01); W. MR 3.0T MR750 W, 00000000UA0082, (DPN26332); X. MR 3.0T MR750W GEM ENABLED, 00001142FMM096, (MPX94401); 00000000UA0425, (DPN36500); Y. MR 3-0T MR750W, 00001309FMM08R , (UE929526); Z. . MR DISCOVERY 750W GEM, 00001117FMM0CP, (PC9595MR01); AA. MR OPTIMA MR750W 3.0T, 00001234FMM0KB, (MRUA0136); BB. MR750W, 00001309FMM072, (MRUA0191); CC. MR750W GEM ENABLED, 00001203FMM0V5, (0835270026); PG75W1600003MR, (ZA2812MR01); DD. MR750W GEM ENABLED PLUS, 00000000UA0486, (00440MRS08); EE. MR750W PGR 32-CHANNEL, 00001309FMM08P, (MRUA0343); FF. 3.0T MR750W GEM ENAB, 00001139FMM0D7, (BY4160MR01)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Medical Systems

All 160

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	Optima XR240amx, Mobile Digital Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR220amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR200amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Giraffe OmniBed Field Replaceable Unit (FRU) recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026Device	CLASS II	Allia IGS 7 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide