Discovery MR750w Nuclear Magnetic Resonance Imaging recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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)

Product

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T…

Recalling firm

GE Medical Systems, LLC

Quantity

516 Units Total

Distribution

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.

Recall date

October 3, 2018

Classification

Class II

Status

Terminated

Agency

FDA (device)