{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140518", "product_res_number": "Z-0254-2016", "event_date_initiated": "2015-08-31", "event_date_posted": "2015-11-10", "recall_status": "Terminated", "event_date_terminated": "2018-09-07", "res_event_number": "72301", "product_code": "LNH", "k_numbers": [ "K132376" ], "product_description": "GE Healthcare, Discovery MR750w 3.0T.\n\nProduct Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.", "code_info": "00000302690MR3\tHCIMR1805 00000290502MR4\tMR129030 00000291489MR3\t415723SHMR10 00000294472MR6\t650723SSMR1 00000290704MR6\t650723SSMR2 00000289310MR5\tHSSMR750 00000289961MR5\tSINAI750MR 00000290457MR1\t608263MR6 00000290050MR4\t281276MR750 00000290659MR2\t610740MR3 00000290202MR1\t415723CHMR2 290957MR0\t608HERIMR 00000290636MR0\tMR129034 00000290137MR9\t650723NCMR1 00000289309MR7\t650723NCMR2 00000291397MR8\t517353DVMR 00000291363MR0\t616391DVMR 00000291980MR1\t704384DVMR 00000292367MR0\tINSIGHTMR3228 00000292471MR0\t804675VA3T 00000288408MR8\t608WAISMR 00000292634MR3\t2486613TMR 00000288907MR9\tMR129035 00000292431MR4\t541CMRIMR 00000290773MR1\t415L3TMR2 00000291877MR9\t415L3TMR1 00000291185MR7\tMSK65MR1 00000292528MR7\t608WIMRMR2 00000291244MR2\tMSK65MR2 00000293338MR0\t206CH750MR 00000291464MR6\t217528MR1 00000292843MR0\t217788MR3 00000294556MR6\t540665MR3T 00000293261MR4\t415OI3TMR 00000293015MR4\t910907WAMR1 00000292678MR0\t919684MR5 00000293561MR7\t405752I3T 00000293874MR4\tHSSGMR750 00000294018MR7\t903525MR750 00000000000641\t434UVAMR 00000294057MR5\t281274MR1 00000294576MR4\t602830MR3 00000294698MR6\t812485MR3 00000294665MR5\t480768MR2 00000294718MR2\t715838MR3T 00000295112MR7\t801377MR3 00000295024MR4\t207945MR750 00000295111MR9\t703391MR2 00000294953MR5\t7579533T 00000295802MR3\t269DVMR 00000295228MR1\t6036503T 00000296046MR6\t309683MNMR750 00000295904MR7\t281477MR2 00000295506MR0\t858822HDMR1 00000296014MR4\t816932DVMR 00000296640MR6\t617726MR1A2 00000296512MR7\t916LST3TMR 00000296461MR7\tMR129037 00000294999MR8\tMSK68MR4 00000295215MR8\t301295MR4 00000296602MR6\t7168453T 00000296821MR2\tDUPONT3T 00000294398MR3\t713441MR9 00000296114MR2\t713441MR8 00000297469MR9\t954772MR1 00000296517MR6\t615MTMR1 00000297974MR8\t810235DVMR 00000297624MR9\t415493VMR2 00000296908MR7\t386FMR3T 00001106XF511E\t202476MR3 00000298283MR3\t616494DVMR 00000298591MR9\t414805MR2 00000298677MR6\t412647PUHMR1 00000298420MR1\t6162673T750 00000298537MR2\t832522MR1 00000298765MR9\t9155693TMR 00000298981MR2\t480425MR6 00000297374MR1\t650PH3T 00000298738MR6\tRADNETMR1593 00000299181MR8\t703858MR3T 00000297637MR1\t650723PSYMR 00000299213MR9\t303699MR2 00000299291MR5\t205592750 00000299250MR1\t847618MR1 00000299321MR0\t509473DMR3T 00000299406MR9\t713792CMR1 00000298580MR2\t570271MR6 00000299515MR7\t816698CP3T 00000299966MR2\t540MIF3T750 00000299329MR3\t209225VC750 000000HDMR6188\t301496MR3T4 00000299544MR7\t703805MR3 00000299908MR4\t425750PMR 00000299331MR9\t720321MR 00000300713MR5\t425688MR 00000299411MR9\t920288MR750 00000301049MR3\t707DG3T 00000300793MR7\tBMDACCMR1 00000300122MR9\t414805MR4 00000301752MR2\t858822HDMR2 00000300562MR6\t202476MR4 00000300732MR5\t805687MR1 00000301924MR7\t312996MR3T 00000299967MR0\t412623MR1 00000301295MR2\t415723SCHMR2 00000302248MR0\t305243MR1 00000301926MR2\t510537MR750 00000303805MR6\t312355DVMR 00000000UA0057\t415723SHMR12 00000302688MR7\t607CORNELL3T 00000000UA0071\t585275MR750W 00000303439MR4\t713566SMITH2 00000304177MR9\t301295MR3T2 0000000UA0032A\t808485MR2 00000301597MR1\tUM750MR 00000304508MR5\t585785MR750 00000304536MR6\t904202MR9 00000304836MR0\t919684BIAC6 00000030493MR0\t602839MR1 00001105XF503F\tASLW750 00000305165MR3\t415723CHMR3 00000290605MR5\t661KRMR750 00000306640MR4\t305284MR1 00000307132MR1\t7347633TMRFIX 00000306641MR2\t212543MR750 00000308791MR3\t415MB3T 00000308357MR3\t650780MR750 00000309403MR4\t918491MR2 00000307553MR8\t415UCBHMR1 00000309564MR3\t415UCBHMR2 00000293065MR9\t918491MR1 00000301599MR7\t703573MR2DV UA0348\tMR229049 N/A\t858657HDMR3 00000310141MR7\tAM12O59187 N/A\t408358SHMR13 00000291429MR9\t0910274032 00000914BD5A87\t0910272064 00001007BD6466\t0910272071 00001011BD663A\t0910272072 00000297898MR9\t2875893 00000295060MR8\tMR13905YR5 00001012BD66AE\tMRWB0558 00001301FMM048\tMRUA0184 00000291154MR3\t519685MR3T 00000291008MR1\t416486MR3T 00000296200MR9\t905527MR1 00000298951MR5\t514345BMR1 00000300711MR9\t514848MR1 00000000UA0042\t403229MR1 00000300563MR4\t905522MR3T 00000303327MR1\t604875MR750 00000299547MR0\t403944MR1 00000296265MR2\t416595MR1 000000000R2726\t902473MR2 00000310044MR3\t082427120132 00001009BD65AC\t082427230048 00001106XF5055\t082427040116 00001106XF5042\t082427150038 00001018XF5019\t082427040119 00001101XF5019\t082427020036 00001106XF502D\t082427090148 00000301753MR0\t082427040121 00001101XF5035\t082427070075 00001106XF5073\t082427040120 00001009BD65A1\t082427210068 00001101XF5016\t082427040123 00001044XF5030\t082427140074 00001012BD6696\t082427230051 00001101XF5033\t082427130057 00001106XF5043\t082427040127 00001106XF50C3\t082427140076 00001101XF5027\t082427100147 00001106XF506B\t082427230055 00001026XF518E\t082427180022 00001048XF500F\t082427210091 00001106XF5090\t082427020039 00001106XF507A\t082427100149 00001106XF504D\t082427090169 00001106XF508A\t082427150047 00001106XF50B4\t082427050028 00001106XF50C5\t082427020042 00001105XF502F\t082427160088 00001106XF508E\t082427070079 00001106XF50DF\t082427040132 00001106XF5125\t082427120092 00001106XF50D7\t082427010056 00001106XF50D0\t082427140087 00001106XF512A\t082427120097 00001106XF50DD\t082427210081 00001106XF508B\t082427040128 00000309404MR2\t082427110049 00001106XF507B\t082427060042 00001106XF5104\t082427100184 00001106XF50B0\t082427030076 00001236FMM01N\t082427210109 00000000WB0792\t082427200076 00001246FMM03C\t082427120107 00001245FMM04P\t082427210111 00001106XF50B6\t082427270037 00000306734MR5\t082427140094 00000310043MR5\t082427130078 00001251FMM013\t082427040135 00000306732MR9\t082427040133 00000306731MR1\t082427310057 00001106XF5105\t082427260003 00001245FMM03W\t082427130071 00001245FMM03L\t082427010072 00001245FMM04R\t082427100202 00001302FMM053\t082427010073 309131MR1\t082427160128 00001301FMM04N\t082427120110 00001302FMM04C\t082427140098 00001302FMM044\t082427150058 00000307111MR5\t082427040142 00000307131MR3\t082427310062 00000308161MR9\t082427090202 00001302FMM04J\t082427050033 00000308162MR7\t082427040137 00001302FMM04M\t082427040141 00001105XF5030\t082427040143 00001302FMM057\t082427120101 00001302FMM04F\t082427040148 00001302FMM04W\t082427210116 00000308210MR4\t082427160114 00000005271M22\t082427210118 00001307FMM04C\t082427200058 00001302FMM04Y\t082427130072 0000000UA0199A\t082427040146 00001302FMM050\t082427310059 00001251FMM01L\t082427120116 00001302FMM04A\t082427040114 00001245FMM04H\t082427210121 00001307FMM08G\t082427160118 00001307FMM07W\t082427040154 00000307615MR5\t082427150062 00001302FMM04U\t082427160101 00001307FMM07V\t082427020056 00001201FMM089\t082427040153 00001302FMM056\t082427100215 00001318FMM009\t082427030092 00001308FMM04N\t082427120124 00001308FMM047\t082427060052 00000309158MR4\t082427100213 00001106XF5089\t082427050029 00001308FMM059\t082427100219 00001406NMM02Y\t082427120129 00001307FMM084\t082427040163 00001302FMM052\t082427180027 00001318FMM006\t082427040161 00000309626MR0\t082427040155 00001406NMM03H\t082427030094 00000309405MR9\t082427270050 00000309560MR1\t082427050034 00000310274MR6\t082427100229 00000310010MR4\t082427140107 00000309742MR5\t082427040165 \t082427010094 \t082427020059 \t082427030100 \t082427040150 \t082427040151 \t082427040172 \t082427060055 \t082427070137 \t082427090241 \t082427100223 \t082427100235 \t082427100241 \t082427110058 \t082427120133 \t082427130075 \t082427140106 \t082427140113 \t082427160136 \t082427210130 \t082427210136 \t082427220040 00001010BD6607\t600110MR01 00000952BD62F0\tEG1793MR01 00000296291MR8\tEG1000MR03 00000294713MR3\tEE4019MR02 00000290985MR1\tM4484966 00000903BD55F9\tM4215566 00001002BD639D\tM40180117 00001009BD6552\tM5484960 00001106XF5064\tM4155416 00001105XF502B\tC4200438 00001105XF5031\tB4498422 00001106XF5114\tM4152248 00001308FMM014\tA4171551 \tM345477701 00000288156MR3\tPC7479MR08 00000914BD5A86\t615010MR01 000001106XF039\tRMUE01MR03 00000912BD59C2\tHC1627MR04 00000293710MR0\tH10645MR17 00001044XF5033\t083027000042711 \t0835270017 00001026XF5151\tIL1020MR04 00000291345MR7\tA5108257 00000294545MR9\tA51152177 00000934BD5E44\tJ5274809 00000905BD567C\tA5279314 00000952BD62F9\tF5119155 00000299454MR9\tB51142110 00001250FMM02V\tMR102094WH0 00000000395M24\tEM0003 00000299147MR9\tEM0004 00001026XF515D\tEM0005 00001027XF5017\tEM0006 00001044XF5031\tEM0010 00000298566MR1\tEM0007 00001026XF5176\tEM0009 00000301194MR7\tEM0012 00001106XF502E\tEM0014 00000301925MR4\tEM0015 00001106XF506C\tEM0018 00001027XF501B\tEM0017 00001026XF516F\tEM0016 00001106XF5094\tEM0002 00001101XF5020\tEM0019 00001106XF507C\tEM0020 00001106XF5068\tEM0022 00000300734MR1\tEM0021 00001106XF503E\tEM0023 00001106XF5134\tEM0030 00001106XF510E\tEM0013 00001227FMM00K\tEM0011 00001215FMM0ME\tEM0024 00001215FMMOMD\tEM0025 00001308FMM00N\tEM0001 00000298331MR0\t0850270341 00000299419MR2\t0850270347 00000300733MR3\t0850270367 00001106XF503D\t0850270351 00001018XF5029\t0850270423 00001026XF515A\t0850270377 00001101XF5039\t0850270370 00001044XF5035\tKW1102MR01 00000926BD5D00\t2806034DVR750 00000302922MR0\tMR302922MR0 00000303872MR6\tMR303872MR6 00001026XF5174\tMRWB0632 00000292216MR9\tRTD0125 00000304910MR3\tAMS0424 00001106XF507E\tRTD0156 00000288409MR6\t0920279028 00000296622MR4\tPL1803MR01 00001105XF5047\tPL2853MR01 00000305118MR2\tMR16061YR4 00001007BD6471\tRU3508MR01 00001106XF502F\tRU1857MR03 00001101XF5022\tRU1086MR03 00000919BD5B81\tSA2180MR02 00001101XF501C\tSA1012MR02 00001101XF5018\tCPZ43623 00001204FMM04P\tDPN26332 00000950BD62C2\tG001MR01 00001011BD6689\tE001MR02 00001106XF505A\tAC001MR01 00000848BD5326\tK002MR02 00001308FMM00A\tA010MR07 00000836BD4DB5\t475290MR01 00001026XF515C\t690120MR01 00001009D6547B\t786090MR06 00001106XF5076\t541010MR04 00000931BD5D88\t0853270103 00000944BD6163\t0853270104 00001009BD65E7\t0853270109 00001101XF5037\t0853270111 00000300792MR9\t0853270117 00001106XF5035\t0853270118 00001106XF5078\t0853270119 00001106XF50C6\t0853270125 00000290456MR3\t70383MRS05 00000291274MR9\t10307MRS03 00001011BD6639\t70065MRS03 00000298501MR8\t00269MRS04 00000931BD5D89\t70328MRS05 00001101XF503B\t00040MRS01 00000301296MR0\t70043MRS05 00001245FMM044\t10197MRS03 00001308FMM053\t10049MRS04 00001308FMM037\t70001MRS11 00000000UA0030\t616774MR750W 00000000UA0073\t415CB3TW 00000000001105\t405271OUCMR 00000000UA0012\t71872MR750W 00000000UA0027\t3014643TMR 00000000UA0031\t928348MR 00000000UA0028\t281274MR2 00000000UA0029\t303604MR2 00000000UA0041\t614GMC3T 00000000UA0038\t61456MR5 00000000UA0046\tRADNETMR597 0000000UA0011A\tRADNETMR1629 00000000UA0048\t815395MR2 00000000UA0053\tRADNETMR1632 00000000UA0055\tRADNETMR598 00000000UA0068\t407SMSLMR1 00000000UA0052\t21277MR1 00000000UA0066\tRADNETMR1635 00000000UA0069\tEAST750W 00000000UA0065\tRADNETMR599 00000000UA0026\t206292SR750W 00000000UA0056\t386FHPCMR3T 0000000UA0001A\t559734VIMR1 00000000UA0060\tRADNETMR1631 00000000UA0074\t337943MR1 00000000UA0083\t408356MR1 00000000UA0085\t305461MR1 00000000UA0075\t619543HDMR4 00000000UA0089\t435251MR1 00000000UA0091\t314577CGMR3T 00000000UA0092\t856247MR3 00000000UA0099\t757827MR2 00000000UA0096\t6033343TW 00000000UA0086\t808545MR 00000000UA0116\t330344MR750W 00000000UA0115\tRADNETMR1639 00000000UA0117\t616267IMRI 00000000UA0050\t708346MR3 00000000UA0062\tRADNETMR1648 00000000001145\tBOSTONMEDMR1 00000000UA0138\t270798MR2 0000000UA0090A\t561844MR1 00000000UA0146\t856581MR3T 00000000UA0141\t757983MR 00000000UA0143\t210617HUBMR 00000000UA0149\tRADNETMR1651 00000000UA0124\t703698MR4 00000000UA0147\t671FHPMR750W 00000000UA0153\t202966MR3TW 00000000005024\t608263MR5W 00000000UA0158\tRADNETMR1652 00000000UA0150\tMR229046 00000000UA0167\t414647MR1 00000000UA0169\t9075653T 00000000UA0175\t808YMMR 00000000UA0174\t217876DMH3T 00000000UA0166\tVAWESTROX750W 00000000UA0144\t337289MR1 0000000UA0103A\t856247MR1 00000000UA0181\t214645UT3TMR1 00000000UA0179\t808873MR750W 00000000UA0193\t301570MR 00000000UA0118\t858622HDMR1 00000000UA0198\t201445750W 726\tBRIGHAM750WMR1 00000000UA0159\t608775MR3T 00000000UA0214\t912819MR 00000000UA0225\tCOR526967 0000000UA0111B\t713798MR1 00000000UA0206\t608CHILDMR1 0000000UA0101B\t702382MR750W 00000000UA0209\t671NAVYMR 0000000UA0132B\t513636MR4 00000000UA0239\t602863MR 0000000UA0067A\tMR229047 00000000UA0244\t937641MR2 00000000UA0242\tMR229048 00000000UA0231\t913322MISHMRW 00000000UA0238\t2148203TMR 00000000UA0232\t864529MR 00000000UA0252\t763795MR1 00000000UA0261\t843815750W 00000000UA0233\t718226MR3T 00000000UA0237\t720854MR 00000000UA0253\t317865MR4 00000000UA0264\t715847MR3T 00000000UA0262\t949760MR3 00000000UA0218\t708346MR4 00000000UA0269\t954355MR750W 00000000UA0260\t207MMC3TMR 00000000UA0283\t410328MR3T 00000000UA0282\t843750WGEM 00000000UA0281\tRADNETMR613 00000000UA0294\t703478MR2DV 00000000UA0234\t510449MR750W 00000000UA0307\tPRESBYMR1 00000000UA0301\tRADNETMR1662 00000000UA0314\t702731MR750W 00000000UA0279\t914750W 00000000UA0296\t309655MR750W 00000000UA0188\t6142343T 00000308347MR4\tMSK68MR6 00000308346MR6\tMSK68MR7 00000000UA0321\t386FNSBMR3T 00000000UA0396\t713792AMR14 N/A\t210AMVAMR UA0326\t614293MR9 00000310301MR7\t904483MR3T 00000309694MR8\t415UCBHMR3 1406NMM0C5\t412914MR 00000000UA0331 \t703573MR1DV UA0224\t503251PMR3 0000000UA0315A\t516NS7113T N/A\t865984MR750 UA0319\t920738MR750 00000309905MR8\tRADNETMR621 00000000UA0355\t716740MR1 UA0368\tMR229050 00000000UA0388\t318443MR2 00000000UA0342\t303837MR2 N/A\t817433HSWMR2 UA0374\t248533750W 00000000UA0203\t225763MR2 00000000UA0139\t847872ZMR2 00000000UA0405\t937208MR1 00000000UA0367\t336832MR750 309219MR4\t734845VA750MR 309815MR9\t4191835 N/A\t9157473TMR 00000000UA0309\t970624MR1 00000000UA0363\tMSK53MR02 00000000UA0402\t480342MR3 00000000UA0421\t608265MR750W 00000000UA0436\t608VAMR750W 00000000UA0443_DUP\t215829MR750W 0000000UA0303A\t718204MR750W \tDZ1638MR01 00001234FMM0KB\tMRUA0136 00001309FMM08P\tMRUA0343 00000000UA0226\t83096535911 00001203FMM0VW\t0910273043 00001236FMM05C\t83096536248 00001250FMM037\t83092403928 00001309FMM057\t83096322711 00001308FMM01D\t83105089955 00001203FMM0VA\t83104203907 00001309FMM09A\t83104653897 00001309FMM099\t83108956002 00001134FMM10P\t0910274040 00000309907MR4\t83112923995 00000309950MR4\t83112923777 00000309423MR2\tAP7645MR01 00001308FMM02N\tBH1017MR01 00001139FMM0D7\tBY4160MR01 00001219FMM0GM\t140024MR01 00001308FMM02R\t220078MR01 00001233FMM06W\t130083MR05 00000000UA0373\t220826MR02 00000310134MR2\t220826MR01 00000000UA0287\t441239MR750W 00000309092MR5\tMRUA0272 00001301FMM03E\tMRUA0122 00001309FMM072\tMRUA0191 00000310252MR2\tBG4680MR01 663\t506648MR4 00000000UA0364\t416249MR2 00000000UA0010\t613737MR1 00000310285MR2\t082427120122 00000310334MR8\t082427210129 00000310608MR5\t082427010080 \t082427010087 \t082427040167 \t082427100225 \t082427110051 \t082427120131 \t082427120135 \t082427130076 \t082427160127 \t082427160149 \t082427180028 00001134FMM10K\tM4166994 00000000UA0016\tX59007321 00001204FMM05C\tN4192951 00001204FMM048\tM2322246 00001204FMM05F\tM45052106 00000303954MR2\tM9481853 00001309FMM0A6\tM4018549 00001307FMM0A1\tM54606125 00001406NMM0CN\tM365865301 00000310422MR1\tX41944010 00000310538MR4\tM4172341 00000310953MR5\tA1765918 \tM4194479 00001117FMMOCN\tPNUE08MR01 00001204FMM05J\tPC9953MR01 00000305145MR5\tUC2547MR01 00001308FMM00L\tHC3068MR01 00001236FMM05D\tHC0220MR03 00001309FMM04U\tPC3003MR01 00000309782MR1\tTP4447MR02 00000301434MR7\tPC9595MR01 00001140FMM0FF\tHU1098MR02 00000000UA0025\t083027848548411 00001221FMM06K\t083027840038612 00001250FMM01T\t083027000013713 00001118FMM0WJ\t083027000049312 00001236FMM05Y\t083027200034313 00001204FMM054\t083027062157412 00001309FMM052\t083027860052014 00000309951MR2\t083027861452415 00000310060MR9\t083027246282014 00000310161MR5\t083027244278914 No Serial \t083027046705715 ACD4001507\t083027200005613 00001203FMM0V5\t0835270026 00000000UA0205\tIE1010MR01 00001203FMM0VY\tB5129925 00001309FMM07R\tB5174327 00001309FMM05G\tA5360437 00000307437MR4\tA5111746 00000310162MR3\tA5547422 00001134FMM10L\tEM0201 00001112FMM081\tEM0202 00000302811MR5\tEM0203 00001117FMM0CE\tEM0204 00001140FMM0FU\tEM0205 00001221FMM0BB\tEM0210 00001233FMM072\tEM0206 00001220FMM01J\tEM0207 00001147FMM0EE\tEM0222 00001203FMMOUW\tEM0212 00001227FMM00V\tEM0211 00001234FMM0KH\tEM0223 00001236FMM00M\tEM0215 00001221FMM06R\tEM0220 00001227FMM00J\tEM0208 00001236FMM01R\tEM0214 00001203FMM0V2\tEM0230 00001220FMM01H\tEM0209 00001236FMM01G\tEM0213 00001140FMM0FL\tEM0218 00001203FMM0VX\tEM0219 00001233FMM076\tEM0250 00001236FMM00X\tEM0216 00000305986MR2\tEM0224 00001147FMM0E8\tEM0217 00001234FMM0KA\tEM0221 00001227FMM00C\tEM0225 00001250FMM01W\tEM0227 00001250FMM02U\tEM0228 00001250FMM02G\tEM0226 00001308FMM055\tEM0231 00001308FMM04T\tEM0229 00001308FMM05B\tEM0234 00001308FMM063\tEM0232 00001301FMM04H\tEM0235 00001236FMM04W\tEM0237 00001301FMM04V\tEM0233 00001236FMM04P\tEM0271 00001308FMM05M\tEM0272 00001236FMM01H\tEM0241 00001236FMM020\tEM0240 00001250FMM02Y\tEM0236 00001308FMM027\tEM0242 00001236FMM016\tEM0238 00001236FMM05E\tEM0239 00001236FMM05U\tEM0246 00001309FMM06A\tEM0245 00001308FMM022\tEM0244 000000HDMR4067\tEM0260 00001309FMM08Y\tEM0243 00001309FMM05Y\tEM0247 00001308FMM01P\tEM0255 00001308FMM020\tEM0256 00001308FMM03L\tEM0248 00001308FMM00E\tEM0253 00001309FMM09Y\tEM0257 00001308FMM012\tEM0254 00001308FMM01Y\tEM0249 00001309FMM08H\tEM0258 00001308FMM01U\tEM0265 00001309FMM095\tEM0275 00000000UA0358\tEM0259 00000308840MR8\tEM0261 00000309816MR7\tEM0262 00000310059MR1\tEM0270 00000310063MR3\tEM0263 00000310420MR5\tEM0266 00000310421MR3\tEM0281 00000310474MR2\tEM0267 00000310475MR9\tEM0264 00000310677MR0\tEM0268 00000310720MR8\tEM0280 \tEM0278 \tEM0279 00000310702MR6\tEM0277 \tEM0269 \tEM0273 00000310839MR6\tEM0276 00000310903MR0\tEM0274 00000310105MR2\tKA1023MR02 00001233FMM06M\t0850270414 00001204FMM04V\t0850270386 00001227FMM00X\t0850270411 00000000UA0170\t0850270427 00001250FMM03E\t0850270426 00000306791MR5\t0850270430 00001221FMM06X\t0850270409 00001308FMM02H\t0850270436 00001309FMM04W\t0850270446 00001309FMM055\t0850270455 00001236FMM05A\tKW1005MR04 00001309FMM096\tKW1019MR03 00000310542MR6\tKW1100MR02 00000301969MR2\tLB1331MR01 00001250FMM028\tLB1160MR02 00001301FMM04M\tLB1006MR02 00000308183MR3\tMR308183MR3 00001147FMM0E6\tUDN0121 00000304860MR0\tRTD0191 00001140FMM0G4\t0920279031 00001308FMM052\t85092252519 00000310773MR7\t85110163303 00001250FMM02P\t600042MR02 00001308FMM05H\tPL3116MR01 00001309FMM0AE\tPL3277MR01 00001308FMM05C\tQA1042MR01 00001204FMM04A\tRO1098MR02 00001234FMM0KG\tRU5599MR01 00000000UA0227\tRU8438MR01 00000000UA0229\tRU8438MR03 00001308FMM03B\tRU8615MR01 00001307FMM08M\tRU8792MR01 00000310164MR9\tRU8937MR01 00000310220MR9\tRU1717MR01 00001135FMM019\tSA1033MR01 00001308FMM064\tSA1223MR01 00001309FMM05E\tSA1255MR03 00000309329MR1\tSA1058MR03 00000000UA0023\t0847270026 00001142FMM096\tMPX94401 00001309FMM08R\tUE929526 00000000UA0425\tDPN36500 00001134FMM10D\tA010MR08 00001251FMM01P\tM001MR02 00001309FMM05J\tN002MR03 00000306343MR5\tM004MR01 00000306349MR2\tO009MR03 00000308132MR0\tT002MR01 00001142FMM092\t120810MR02 00000000UA0049\t850020MR02 00001250FMM039\t387040MR10 00001309FMM06W\t725100MR02 00000309270MR7\t150250MR01 \t259130MR12 00001308FMM048\t0853270141 00000310604MR4\t0856270071 00001204FMM04B\t34348MRS01 00001227FMM00N\t26001MRS01 00000000UA0349\t53008MRS01 00000309272MR3\t06162MRS01 00000000UA0097\tAE1016MR01 00001111FMM0B7\t70431MRS04 00001250FMM038\t00010MRS02 00000000UA0265\t00230MRS01 00001309FMM04T\t10692MRS01 00001309FMM07M\t77266MRS03 00000310701MR8\t20312MRS01 00000302616MR8\t10639MRS01 00000302669MR7\t10678MRS01 00000309906MR6\tMRUA0353", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.", "root_cause_description": "Software design", "action": "GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "756", "distribution_pattern": "Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.", "openfda": { "k_number": [ "K253489", "K072473", "K111803", "K222968", "K121160", "K900289", "K253648", "K902310", "K921653", "K122613", "K003899", "K183254", "K261331", "K251397", "K933296", "K151579", "K243547", "K910817", "K171778", "K923581", "K040444", "K013858", "K911872", "K992746", "K923022", "K902314", "K926397", "K203553", "K944331", "K020164", "K203443", "K914209", "K940772", "K920543", "K920254", "K992120", "K955389", "K092899", "K181370", "K981898", "K925286", "K933645", "K192924", "K221619", "K915754", "K935084", "K941408", "K932552", "K133526", "K920098", "K183685", "K945730", "K160618", "K925985", "K223203", "K041476", "K143253", "K984280", "K153740", "K911276", "K090433", "K900283", "K012202", "K925845", "K962117", "K043030", "K203323", "K163312", "K072279", "K921940", "K883482", "K932645", "K103411", "K983110", "K990260", "K962618", "K883648", "K890394", "K912410", "K033168", "K991652", "K010570", "K890855", "K926571", "K032541", "K895794", "K092308", "K003947", "K223439", "K905104", "K932271", "K954354", "K931298", "K133692", "K951681", "K913770", "K001773", "K162183", "K901818", "K910220", "K163192", "K212419", "K203451", "K903754", "K932693", "K130885", "K002179", "K180592", "K212456", "K171597", "K901305", "K033315", "K024042", "K220018", "K011418", "K933297", "K083147", "K930960", "K251386", "K993682", "K172110", "K041695", "K142734", "K192852", "K954353", "K921609", "K961624", "K013586", "K935570", "K940534", "K113093", "K080968", "K942669", "K963990", "K923823", "K884743", "K083137", "K895869", "K924605", "K183231", "K162940", "K930708", "K964752", "K900286", "K911642", "K202170", "K113490", "K241242", "K250901", "K944070", "K121997", "K962933", "K896508", "K031350", "K163211", "K181322", "K900919", "K945945", "K250443", "K964306", "K113337", "K011416", "K971380", "K052423", "K240238", "K960181", "K030918", "K945665", "K232346", "K193097", "K081916", "K943021", "K192506", "K220335", "K990153", "K992412", "K902663", "K192574", "K230972", "K884607", "K925029", "K103330", "K984224", "K201540", "K073081", "K974498", "K991943", "K052987", "K190017", "K981410", "K052172", "K061429", "K241496", "K963345", "K971055", "K121545", "K903204", "K890092", "K103238", "K190138", "K922677", "K901602", "K252239", "K894016", "K063559", "K925858", "K003453", "K203280", "K011466", "K913463", "K935627", "K900285", "K915567", "K885047", "K900727", "K902315", "K033504", "K002225", "K133670", "K891543", "K955811", "K210843", "K901864", "K945827", "K964370", "K883516", "K990826", "K241607", "K941622", "K251808", "K893744", "K230208", "K950973", "K913325", "K170978", "K883898", "K052164", "K884484", "K243122", "K182282", "K924921", "K942355", "K053009", "K160185", "K023686", "K160621", "K893881", "K961238", "K943321", "K951649", "K920095", "K183244", "K942609", "K242524", "K911975", "K921891", "K120701", "K974614", "K923140", "K032490", "K141977", "K241925", "K120638", "K990968", "K190757", "K260113", "K181433", "K905603", "K232760", "K915552", "K942873", "K090080", "K922846", "K202238", "K110802", "K911495", "K920204", "K896647", "K220589", "K945778", "K160632", "K950837", "K903755", "K931460", "K920199", "K002531", "K002415", "K893739", "K212233", "K143345", "K954039", "K942953", "K210340", "K914263", "K211818", "K110151", "K121650", "K223079", "K920215", "K943799", "K884604", "K926416", "K110238", "K972826", "K933018", "K052571", "K905441", "K892235", "K941864", "K043290", "K003628", "K201722", "K003192", "K960294", "K113511", "K132831", "K192690", "K163116", "K022157", "K142421", "K920227", "K063361", "K172878", "K924489", "K945875", "K930674", "K052978", "K220425", "K260852", "K980645", "K123510", "K113145", "K183063", "K151074", "K934318", "K923010", "K032082", "K230758", "K944773", "K990550", "K233673", "K941666", "K963186", "K163331", "K062454", "K220575", "K061930", "K923423", "K253625", "K992135", "K242573", "K083533", "K213668", "K900287", "K893689", "K073457", "K893675", "K211980", "K980114", "K930544", "K000315", "K930709", "K953248", "K082485", "K033867", "K080098", "K221785", "K221025", "K031731", "K930122", "K150427", "K893518", "K994351", "K031396", "K210611", "K221393", "K170090", "K211118", "K902630", "K894290", "K891760", "K902933", "K072237", "K915873", "K093984", "K111242", "K200024", "K020289", "K964778", "K883521", "K232494", "K932644", "K012875", "K211406", "K912095", "K201141", "K910513", "K202210", "K072850", "K000832", "K935224", "K260746", "K132951", "K953918", "K010773", "K130115", "K926275", "K925107", "K921413", "K173356", "K935661", "K915395", "K932403", "K180925", "K203372", "K964531", "K050602", "K974212", "K063207", "K911348", "K193102", "K905615", "K142085", "K253499", "K901888", "K001796", "K250436", "K162931", "K932244", "K120778", "K183274", "K192650", "K925597", "K913673", "K923944", "K904327", "K944979", "K951650", "K041577", "K911892", "K213583", "K223523", "K232644", "K072998", "K981398", "K010057", "K013636", "K080762", "K240608", "K082331", "K013150", "K162403", "K231617", "K980306", "K933658", "K153324", "K915579", "K905070", "K963953", "K935664", "K111226", "K962892", "K132376", "K041111", "K960901", "K935752", "K052698", "K974530", "K990329", "K014011", "K935549", "K073156", "K211633", "K953262", "K200327", "K900284", "K920441", "K122006", "K233629", "K003651", "K193282", "K934396", "K071099", "K994287", "K252379", "K983793", "K091166", "K961121", "K901980", "K941996", "K894714", "K252838", "K173224", "K130692", "K240157", "K942604", "K914019", "K002964", "K935671", "K123068", "K911991", "K053309", "K080038", "K231587", "K922006", "K050132", "K940874", "K943320", "K923025", "K092469", "K232680", "K041020", "K001894", "K911800", "K023511", "K143008", "K183222", "K170412", "K191032", "K212673", "K963262", "K920097", "K002997", "K915260", "K043271", "K890789", "K023207", "K191036", "K893509", "K151466", "K062860", "K931022", "K992533", "K092230", "K023130", "K112003", "K974844", "K142997", "K181093", "K191050", "K143020", "K212271", "K903319", "K945517", "K011485", "K013344", "K932292", "K921098", "K944228", "K940514", "K905833", "K251029", "K934538", "K883650", "K231459", "K192002", "K883378", "K905512", "K903028", "K883756", "K161397", "K970990", "K253780", "K913475", "K120487", "K923870", "K232482", "K080515", "K972704", "K901730", "K231133", "K183657", "K232981", "K010850", "K020268", "K222259", "K253779", "K133848", "K220332", "K211037", "K982959", "K940894", "K241133", "K121434", "K033507", "K932374", "K883649", "K913563", "K931544", "K923897", "K925009", "K002242", "K170840", "K945791", "K242825", "K920578", "K210164", "K220939", "K901639", "K910715", "K210415", "K905858", "K203053", "K926001", "K223875", "K944662", "K123417", "K042236", "K012200", "K133490", "K903822", "K071154", "K924653", "K121676", "K173382", "K002490", "K251822", "K090873", "K962927", "K890815", "K896789", "K933835", "K981475", "K934212", "K910514", "K944112", "K911746", "K941582", "K923984", "K910802", "K223442", "K241331", "K190524", "K181613", "K902316", "K101347", "K930811", "K202030", "K233733", "K905835", "K895629", "K911806", "K131241", "K230187", "K003623", "K970852", "K140956", "K173507", "K884369", "K242258", "K213603", "K151015", "K883994", "K921881", "K211983", "K924479", "K230152", "K251399", "K961092", "K100352", "K240571", "K944469", "K922798", "K010691", "K171128", "K883547", "K903753", "K251682", "K901620", "K193218", "K901242", "K901241", "K915657", "K131896", "K131996", "K902799", "K042948", "K190461", "K110942", "K153003", "K181479", "K091669", "K223343", "K970573", "K934719", "K102344", "K142515", "K940364", "K925987", "K945779", "K132381", "K911959", "K170396", "K912963", "K923881", "K022397", "K003853", "K143251", "K910498", "K915112", "K924808", "K945798", "K231560", "K033485", "K896309", "K142361", "K942560", "K921046", "K122034", "K240744", "K920094", "K905634", "K250246", "K924154", "K973799", "K193116", "K883622", "K903661", "K012154", "K935450", "K935691", "K943415", "K945828", "K932091", "K081028", "K945397", "K002420", "K024066", "K251937", "K173592", "K883872", "K905095", "K924756", "K083421", "K003516", "K043147", "K102489", "K153547", "K232535", "K983902", "K931008", "K052023", "K173558", "K020991", "K883520", "K920789", "K052013", "K932338", "K984221", "K971668", "K091444", "K162722", "K965044", "K202518", "K250379", "K091536", "K213305", "K101295", "K970037", "K920791", "K923264", "K141945", "K123938", "K241429", "K905442", "K182299", "K032232", "K071925", "K183137", "K162943", "K981190", "K960497", "K893750", "K121239", "K895151", "K930779", "K233728", "K961174", "K193324", "K934987", "K920159", "K153447", "K151668", "K921941", "K161795", "K182129", "K223247", "K894974", "K060003", "K212056", "K030874", "K240944", "K884603", "K900288", "K905834", "K213805", "K963179", "K041112", "K192851", "K031230", "K130658", "K012970", "K935369", "K912881", "K914012", "K903203", "K900064", "K223426", "K962061", "K982761", "K982834", "K203653", "K903768", "K901952", "K933295", "K920096", "K883737", "K060956", "K993731", "K923352", "K891598", "K935015", "K903318", "K920714", "K920835", "K073099", "K935670", "K213717", "K980417", "K954355", "K223458", "K903048", "K093336", "K983327", "K945386", "K952232", "K132160", "K031927", "K203279", "K122026", "K920126", "K161567", "K933659", "K883699", "K971279", "K921720", "K011296", "K002611", "K221733", "K961876", "K250236", "K994316", "K073167", "K962249", "K954646", "K992892", "K891769", "K061132", "K102155", "K942875", "K020573", "K123522", "K032795", "K181371", "K220151", "K202767", "K990620", "K070968", "K092925", "K003573", "K162102", "K153039", "K173749", "K050200", "K964753", "K893619", "K900026", "K911993", "K221923", "K914114", "K952530", "K082427", "K924426", "K254277", "K933356", "K963429", "K232322", "K971884", "K895328", "K243335", "K902217", "K180926", "K913534", "K100164", "K984274", "K153343", "K073425", "K883621", "K943189", "K900728", "K113281", "K050237", "K000802", "K994283", "K252371", "K213693", "K964608", "K902044", "K993803", "K926171", "K910269", "K944724", "K160152", "K103507", "K934485", "K923615", "K031815", "K193176", "K232765", "K982932", "K082964", "K923948", "K941025", "K240540", "K173409", "K140253", "K130262", "K943440", "K041602", "K131737", "K022390", "K111340", "K041286", "K032428", "K183621", "K943798", "K990335", "K930193", "K233687", "K991243", "K243667", "K891541", "K251276", "K193200", "K001987", "K905578", "K052315", "K092253", "K883519", "K202014", "K896336", "K934499", "K913441", "K191128", "K133435", "K201616", "K073362", "K931656", "K061916", "K945155", "K213960", "K962138", "K884606", "K183221", "K940602", "K924349", "K173451", "K113394", "K141472", "K940541", "K994117", "K140666", "K222387", "K982157", "K993574", "K253413", "K914535", "K922470", "K052579", "K903770", "K032121", "K972990", "K932344", "K973658", "K930991", "K905832", "K884816", "K940796", "K942874", "K960973", "K080048", "K052305", "K030520", "K901092", "K911667", "K061255", "K946085", "K201389", "K930045", "K043112", "K202966", "K180100", "K220192", "K260265", "K920125", "K082100", "K173079", "K896419", "K903527", "K201039", "K091580", "K192426", "K992225", "K892959", "K132119", "K173600", "K212367", "K931454", "K012495", "K192496", "K962677", "K915598", "K895221", "K001334", "K900889", "K942776", "K032678", "K915601", "K253862", "K120748", "K941812", "K932375", "K050199", "K193215", "K213516", "K152283", "K103327", "K890666", "K895966", "K922000", "K191157", "K043262", "K172920", "K943800", "K924472", "K172685", "K052293", "K182756", "K884062", "K900725", "K243397", "K952235", "K905366", "K914536", "K030981", "K971684", "K101813", "K143606", "K893640", "K251901", "K980831", "K092237", "K964626", "K230355", "K173617", "K052078", "K961842", "K093738", "K910839", "K193021", "K181593", "K061368", "K965068", "K934514", "K994282", "K905259", "K894855", "K904528", "K946244", "K201615", "K040877", "K931392", "K901384", "K962048", "K913869", "K143128", "K152371", "K232030", "K912539", "K232361", "K161973", "K222755", "K961969", "K242006", "K122035", "K961366", "K191662", "K885223", "K161238", "K895131", "K090038" ], "pma_number": [ "P860062", "P840007", "P860010", "P830074", "P830051", "P840063", "P830053", "P830081", "P830052", "P830076", "P850043" ], "registration_number": [ "", "3016727312", "3005877899", "3027339477", "3016591365", "1526534", "3012169560", "1319639", "3018094310", "3017383732", "3018004899", "3015425142", "3033536331", "3010701021", "3013695852", "3014680716", "3004977335", "3005976071", "3006239787", "3032109181", "3016851825", "3008496839", "3012085143", "2520313", "3036666444", "3011950073", "2247992", "9616047", "3011015597", "3014111222", "3012761544", "3004754211", "3035950510", "3026047529", "3014343100", "3010009632", "3010398867", "3031503890", "3042177665", "3008156140", "3004929307", "3011106828", "3015431711", "3009755250", "3007734888", "2134213", "3013875850", "9617277", "3006262888", "1723170", "3015276088", "3021593788", "3009196578", "3018423337", "3005049692", "1932738", "1826555", "3014809646", "3017297314", "3034286426", "3011416394", "9614698", "1058584", "3014232555", "3008355361", "1650907", "3026391023", "3009963139", "3007546534", "3005450718", "3021059265", "3019595609", "3011767965", "3003494057", "3033333119", "3019844073", "3003661577", "1721113", "3008986341", "2432211", "1054713", "3009154005", "3027325776", "3027373189", "3009077524", "1529041", "3023385454", "3015329423", "2029299", "3023003446", "3004531751", "3012127758", "3013679558", "9613936", "1835830", "2011171", "3020162557", "1038814", "1221108", "1055916", "3015232217", "3005517190", "3006073271", "3006849754", "3012075008", "3010703925", "9611343", "3009715136", "3015223550", "3007350713", "3012354318", "9617016", "3033527281", "3008447096", "3010949642", "3006015847", "3009882464", "3008284470", "2183553", "3002808157", "3005326970", "3007562060", "3032109225", "3003768277", "2126677", "3006738448", "8043485", "3004859018", "3006621332", "3014635027", "1063285", "3004994584", "3009504230", "3005810333", "3004526608", "3008632256", "3006369484", "3017375271", "3010326005", "3012939903", "3007545404", "3009714754", "3014310698", "3011657336", "3012439308", "3029521953", "3000126629", "3030982377" ], "fei_number": [ "", "3016727312", "3005877899", "1937223", "3027339477", "3016591365", "1526534", "3012169560", "3018094310", "3017383732", "3018004899", "3015425142", "3033536331", "3010701021", "3013695852", "3014680716", "3004977335", "3005976071", "3006239787", "3032109181", "3016851825", "3008496839", "3012085143", "1000403400", "2520313", "3036666444", "3011950073", "1000138054", "3011015597", "3014111222", "3012761544", "3004754211", "3035950510", "3026047529", "3014343100", "3010009632", "3010398867", "3031503890", "3042177665", "3008156140", "3003190524", "3004929307", "3011106828", "3015431711", "1000219637", "3009755250", "3007734888", "1000306474", "3001814065", "3013875850", "3006262888", "3015276088", "3021593788", "3009196578", "3018423337", "3005049692", "1826555", "3014809646", "3017297314", "3011416394", "3014232555", "3008355361", "1000517638", "3026391023", "3009963139", "3007546534", "3005450718", "3003377038", "3021059265", "3019595609", "3011767965", "3003494057", "3033333119", "3019844073", "3003661577", "1721113", "3008986341", "2432211", "3009154005", "3027325776", "3027373189", "1000113348", "3009077524", "3002808382", "3023385454", "3015329423", "1000208827", "3023003446", "3004531751", "3012127758", "3013679558", "3005214683", "3002807880", "2011171", "3020162557", "3002806900", "1038814", "3001654007", "1221108", "3015232217", "3005517190", "3006073271", "3006849754", "3012075008", "3010703925", "3002681132", "3009715136", "3015223550", "3007350713", "3012354318", "3033527281", "3008447096", "3010949642", "1000114111", "3006015847", "1000284313", "3009882464", "3008284470", "2183553", "3002808157", "3005326970", "3007562060", "3032109225", "2126677", "3006738448", "3004859018", "3006621332", "3014635027", "1000571342", "3004994584", "3009504230", "3005810333", "1000143606", "3008632256", "3004526608", "3017375271", "3010326005", "3006369484", "3002806926", "3012939903", "3007545404", "3009714754", "3014310698", "3011657336", "3012439308", "3029521953", "3000126629", "3030982377" ], "device_name": "System, Nuclear Magnetic Resonance Imaging", "medical_specialty_description": "Radiology", "regulation_number": "892.1000", "device_class": "2" } } ] }