—#165066

Product

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..

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142085
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

GE Medical Systems notified customers on or about 06/06/2018 via a customer letter entitled "Urgent Medical Device Correction". The letter directed its customers to continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning. Safety information included the following: WARNING: Place appropriate non-conductive padding between the patient and the bore wherever a portion of the body may come into contact with the magnet opening. CAUTION: Continuous patient observation and contact are required in all modes of operation. CAUTION: Extra attention should be utilized when scanning patients who are unconscious, sedated, or may have loss of feeling in any body part or are physically or mentally impaired and unable to alert the personnel. If a brown discoloration is seen on the inner surface of the patient bore, or if a burning smell is noticed, please contact your local Service Representative. The letter also stated GE Healthcare will correct all affected products at no cost. A GE Healthcare representative will contact customers to arrange for the correction. The firm could also be contacted by calling a GE Healthcare Service at 1-800-437-1171 or a local Service Representative.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3200 N Grandview Blvd, Waukesha, Wisconsin 53188-1693

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-06-06
Terminated: 2022-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165066. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.