Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name ...
FDA Device Recall #Z-3279-2018 — Class II — June 6, 2018
Recall Summary
| Recall Number | Z-3279-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 6, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 516 Units Total |
Product Description
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..
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.
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.
Lot / Code Information
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)
Other Recalls from GE Medical Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1590-2026 | Class II | Imactis CT-Navigation System, stereotaxic acces... | Feb 3, 2026 |
| Z-1569-2026 | Class II | Centricity Universal Viewer Software Versions 7... | Jan 30, 2026 |
| Z-1570-2026 | Class II | Centricity Universal Viewer Software Versions 6... | Jan 30, 2026 |
| Z-1571-2026 | Class II | Centricity Universal Viewer Software Versions 5... | Jan 30, 2026 |
| Z-0875-2026 | Class II | Senographe Pristina, Pristina Serena, and Prist... | Oct 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.