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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare MRI Systems, Software Version 15.x or HD 16

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  Class 2 Device Recall GE Healthcare MRI Systems, Software Version 15.x or HD 16 see related information
Date Initiated by Firm June 07, 2018
Create Date October 15, 2018
Recall Status1 Terminated 3 on June 18, 2020
Recall Number Z-0112-2019
Recall Event ID 80323
510(K)Number K012200  K013636  K030874  K040444  K041476  K052293  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names:

*ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX ECHOSPEED 16 CH, 1.5 HDX ECHOSPEED 8 CHANNEL, 1.5 HDXT, 1.5 HDXT-16 , 1.5 LX TO HDX 16C FORKLIFT UPG, 1.5 LX TO HDX 8C FORKLIFT UPG, 1.5 T UPGRADE TO HDX, 1.5EXCIT TO HDXT UPG, 1.5T HDX 16 CHANNEL, 1.5T 16CH UPG, 1.5T 6 CH HDX , UPGRADE, 1.5T 8CH HDXT TO 16CH HDXT UPG, 1.5T CRM LX TO HDX UPG, 1.5T ES HDX W/ONCOLOGY PACK, 1.5T EXC.TO HDX UPG, 1.5T EXC.TO HDXT UPG, 1.5T EXCITE HD TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG. W/ACGD, 1.5T EXCITE TO HDXT UPG, 1.5T EXCITE TO HDXT UPGRADE, 1.5T EX-HDX, 1.5T EX-HDXTWIN, 1.5T HD ES/HS MOBILE, 1.5T HD TO HDX UPG. 1.5T HD TO HDX UPGRADE, 1.5T HD TO HDXT UPG, 1.5T HD TO HDXT UPGRADE
1.5T HDI,1.5T HDI 16CH FIXED, 1.5T HDI 8CH FIXED, 1.5T HDI ECHOSPEED
1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHANNEL
1.5T HDI ECHOSPEED 8 CHANNEL., 1.5T HDI ECHOSPEED 8 CHANNEL,
1.5T HDI ECHOSPEED 8 CHAN¿SO2762285, 1.5T HDI ECHOSPEED 8CH,
1.5T HDI ECHOSPEED MOBILE, 1.5T HDI ECSHOSPEED 8CH, 1.5T HDI TO HDXT UPGRADE, 1.5T HDX, 1.5T HDX - MEIRAV (BREAST), 1.5T HDX 8CM
1.5T HDX ECHOSPD 16, 1.5T HDX ECHOSPEED, 1.5T HDX ECHOSPEED
1.5T HDX ECHOSPEED 16, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNELS, 1.5T HDX ECHOSPEED 16CH¿SO2659508, 1.5T HDX ECHOSPEED 16CH-SO2718893, 1.5T HDX ECHOSPEED 32 CHANNEL, 1.5T HDX ECHOSPEED 8 CH, 1.5T HDX ECHOSPEED 8 CHANNEL, 1.5T HDX ECHOSPEED MOBILE
1.5T HDX ECHOSPEED MRI, 1.5T HDX ES, 1.5T HDX ES 16, 1.5T HDX TWINSPEED, 1.5T HDX TWINSPEED 16 CHANNEL, 1.5T HDXT
1.5T HDXT 16CH,1.5T HDXT 16CH CXK4, 1.5T HDXT 16CH ES FIXED
1.5T HDXT 8 CH, 1.5T HDXT 8CH ES FIXED, 1.5T HDXT 8CH UP, 1.5T HDXT ECHOSPEE, 1.5T HDXT ECHOSPEED, 1.5T HDXT ECHOSPEED 16 CH
1.5T HDXT ECHOSPEED 16 CHAN, 1.5T HDXT ECHOSPEED 16 CHANNEL
1.5T HDXT ECHOSPEED 8, 1.5T HDXT ECHOSPEED 8 CHANN, 1.5T HDXT ECHOSPEED 8 CHANNEL, 1.5T HDXT ECHOSPEED 8 CHANNEL , 1.5T HDXT ECHOSPEED 8_CHANNEL, 1.5T HDXT ECHOSPEED MOBILE, 1.5T HDXT ES 8 CH, 1.5T HDXT GS, 1.5T HDXT TWIN, 1.5T HDXT TWINSPEE, 1.5T HDXT TWINSPEED 16 CHAN,1.5T HDXT UPG, 1.5T HDXTID, 1.5T LX HDX, 1.5T LX TO 16 CH HDXT UPG, 1.5T LX TO 16 CHAN, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPGRADE, 1.5T LX TO 16 CHANNEL HDXT, 1.5T LX TO 16 CHANNEL HDXT UPG, 1.5T LX TO 16CHANNEL HDX U/G2777896, 1.5T LX TO 8 CH HDX UPG, 1.5T LX TO 8 CH HDXT UPG, 1.5T LX TO 8 CHANNEL HDX UP, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG.827015, 1.5T LX TO 8 CHANNEL HDXT UPG, 1.5T LX TO 8 CHANNEL HDXT UPGRADE, 1.5T LX TO HDXT
1.5T NON LCC4X5X TO HDXT UPGD, 1.5T NON-LCC LX/HRZ 5.5 TO 1.5T HDX, 1.5T SIGNA HDX UPG, 1.5T SIGNA HDXT, 1.5TEXCITE TO HDX UPG W/O A, 1.5TEXCITE TO HDX UPG W/O ACGD, 1.5TNONLCC LXHZ TO HDXT UPG, 1.5TNONLCC LXHZ TO HDXUPGW/ACD, 1.5TNONLCC4X5X TO HDXUPGW/OACD, 1.5TNONLCCLXHZ TO HDXUPGW/O ACD, 1¿5T 8CH HDXT MRI, 1¿5T HDXT, 1¿5T HDXT MRI, 1-5T CRM LX TO HDX , G.W/OACGD, 1-5T CRM LX TO HDXT UPG, 1-5T EXCITE TO
15T EXCITE TO HDX UPG, 1-5T HDI ECHOSPEED 16 CHANNEL, 15T HDI ECHOSPEED 8 CHANNEL, 1-5T HDX ECHOSPEED 16 CHANN, 15T HDX ECHOSPEED 16 CHANNEL, 15T HDX ECHOSPEED 8 CHANNEL, 15T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED TRANSPORT, 1-5T HDX TWINSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED 16, 1-5T HDXT ECHOSPEED 16 CHAN, 1-5T HDXT ECHOSPEED 16 CHAN-HD16.0, 1-5T HDXT ECHOSPEED 16 CHANNEL,
1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 UPGRADE, 1-5T HDXT ECHOSPEED 8 CHANN, 15T HDXT ECHOSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED MOBILE, 1-5T HDXT ECHOSPEED RELOCATABLE, 1-5T LX TO 16 CHANNEL HDX UPG, 1-5T LX TO 16 CHANNEL HDXT, 1-5T LX TO 8 CHANNEL HDXT U, 1-5T LX TO
Code Information Model Number, Serial Number (System ID) :  N/A, 000000000R7742 (MP697620); N/A, 00000834BD4B76 (M2865810);  46-294231G1, 0002005-0607-9 (80040MRS02); N/A, 00000293242MR4 (GOLD00EU79); 5127452, 00000274388MR8 (M4160077); 2226300, 000000000R7586 (PL2130MR01); 2226300, 000000000R2785 (A5106403);  N/A, N/A (083027060000499); 2226300, 000000000R5870 (A5177224);  N/A, 000000000R4933 (C4194430); 2226300, 000000000R7628 (PL1807MR01); 5911000-4 , 00001201FMM0FJ (083027829345912);  2226300, 000000000R5979 (818713MR1); 5308573, 00000292202MR9 (706378MR2); 46-294231G1, 002003-1211-30 (KW1005MR02); 2226300, 000000000R5829 (PL1677MR01); 46-294231G1, 000099-1119-10 (A5401507); N/A, N/A (083027040099711); 46-294231G1, 002001-0530-21 (0920279017); 2377062-61, 00000010633YR6 (808433TMR2);  46-294231G1, 002001-1001-91 (PC1961MR01); 5308573, 00000300778MR8 (0856270046); 2226300, 000000000R5217 (PL1649MR01); N/A, N/A (PL0195MR01); 2226300, 000000000R4456 (70772MRS90); 5127452, 000000HDMR6307 (DK1297MR01); 2226300, 000000000R1970 (M4018076);  46-294231G1, 0000094-1209-4 (178SIGNA15); 2377062-2, 00000963500YM4 (0910272057); 46-294231G1, 002004-0211-05 (PC2703MR02); 46-294231G1, 002001-0301-23 (YM0731); 46-294231G1, 002003-0128-22 (YM2020); 2226300, 000000000R5133 (KAISERVJOMR); 5127452-3, 00001011BD6645 (082427040110); 46-294231G1, 0000098-0617-2 (414SIGNAHOR); 5308573, 00000294505MR3 (34407MRS01); 5107849, 00000275094MR1 (DZ1004MR02); 2226300, 000000000R6384 (0850270266); N/A, 00000000R7803A (2900429); 2214149-2, 00000003388M26 (MRR8311); N/A, 000000000R6449 (110040MR01); 2214149-2, 00000001634M25 (MRR8049); /A, N/A (0910272067); 2226300, 000000000R6691 (A200581902);  2226300, 000000000R6343 (787831SIGNAHDX); 2226300, 000000000R6461 (SA2161MR01); 2226300, 000000000R7934 (78003MRS01); 5308573, 00000291238MR4 (MA1135MR01); 5308573, 00000299348MR3 (07025MRS01); 2226300, 000000000R7004 (PL1426MR02); 2226300, 000000000R7487 (1306777); 2226300, 000000000R6769 (IL1041MR08); 395001, 00000280692MR5 (CC0820MR09); 2226300, 000000000R6889 (PL1735MR01); N/A, 000000000R6609 (M4464817); 2226300, 000000000R6707 (083027207801078); N/A, 00000014680GQ3 (M4033099);  5127452, 000000HDMR3604 (01203MRS01); N/A, N/A (0910274028);  2226300, 000000000R6050 (10563MRS01); 2226300, 000000000R5325 (SA1056MR01); 2226300, 000000000R6042 (SA1047MR01);  46-294231G1, 0002001-0219-8 (281477MWMR); 2226300, 000000000R5823 (A5718006); 2226300, 000000000R6111 (DZ1250MR01); N/A, N/A (DK1228MR07); 46-294231G1, 0000098-1207-9 (IE1028MR02); 2226300, 000000000R5149 (00398MRS01); 2226300, 000000000R5639 (00441MRS01);  2226300, 000000000R7809 (CBSMR1); 2226300, 000000000R5836 (083027862100837); 46-294231G1, 000004-0528-17 (083027602200104);  2226300, 000000000759 (083027603014911); N/A, 002004-0323-16 (GOLD0EU131); 2226300, 000000000R7996 (MRR7977); 2226300, 000000000R7781 (PL1639MR02); N/A, 000000000R7452 (2869229);  N/A, N/A (HC2821MR01); 5308573, 00000294659MR8 (083027848131849);  46-294231G1, 0002000-1003-3 (0835270003); 2226300, 000000000R7237 (M4212028); 2395001, 00000276676MR4 (083027842100686); N/A, N/A (0910272088); N/A, N/A (0859270005); 2226300, 000000000R7837 (2913994HDXT); 5127452-3, 00001011BD667C (DZ1005MR01); 2226300, 000000000R7563 (IR1906MR01); 5911000-4 , 00001239FMM01H (083027800039612); 5127452-3, 00000919BD5B8F (FI1024MR02);  2226300, 000000000R7940 (SA2214MR01); 5127452-3, 00000837BD4ESC (0850270435); 46-294231G1, 000006-0523-15 (0850270200); 5127452-3, 00001003BD6435 (083027601000510); 5308573, 00000302567MR3 (083027243783711); 2377062, 00000941265YM1 (600118MR02); N/A, N/A (0850270291); 2395001-3, 00000289020MR0 (083027202100488); 2226300, 000000000R2404 (PL1169MR01); N/A, N/A (083027601013710); N/A, N/A (0910274011); 46-294231G1, 0000099-0506-1 (0910272025); 5127452, 000000HDMR5710 (IE1038MR01); N/A, N/A (083027001018110); N/A, N/A (083027592052828); 2226300, 000000000R4321 (SA1220MR01); 46-294231G1, 002002-1015-30 (PC0114MR04); 46-294231G1, 002003-0820-07 (PL1394MR01); 46-294231G1, 002001-0619-24 (IE1006MR01); 2226300, 0000000000R891 (0920279013); N/A, N/A (0910272038); 46-294231G1, 002000-0418-17 (SA1001MR02); 46-294231G1, 0`2001-0219-13 (259170MR05); N/A, 0000099-1217-4 (10140MRM44); N/A, 00000303865MR0 (10331MRS01); 46-294231G1, 0000096-0614-8 (801224MR); N/A, 0000096-0520-5 (AE1025MR01); 46-294231G1, 002001-0709-20 (0856270038);  5308573, 00000301170MR7 (MRR8186); 5127452, 000000HDMR6250 (00213MRS01); 46-294231G1, 002004-0917-09 (600092MR03); N/A, N/A (0856270050); 46-294231G1, 0000097-0922-9 (213340MR); 46-294231G1, 0000094-0928-7 (4224SIGN15); 5127452, 000000HDMR5751 (70383MRS01);  N/A, N/A (083027592002609); 5127452-3, 00000903BD55FD (083027002100119); 2226300, 000000000R7217 (083027848480709);  5127452, 00000HDMR10911 (801262MR2); 46-294231G1, 002001-0425-10 (765INNERMR); 2377062, 00000962578YM1 (519685MR); 2377062-61, 00000009061YR3 (DK1401MR01); 2226300, 000000000R6839 (501268MR);  5308573, 00000301743MR1 (45019MRS01); 5127452, 000000HDMR6310 (0834270012); 2226300, 000000000R6802 (H10649MR06); 5107849-2, 00000288195MR1 (H10652MR08); 2395001, 00000286008MR8 (21234MRM02); 2108800-2, 535651 (SHIMR02604); 2226300, 000000000R6903 (503763MR1); 46-294231G1, 002002-0627-18 (RADNETMR611); N/A, N/A (083027820006912); N/A, N/A (4954MR15T);  N/A, 000000000R6911 (2805953); 46-294231G1, 0000091-1022-5 (205431MR2); 5911000-4 ,00001227FMM06G (083027200018712);  N/A, N/A (083027590475005); N/A, N/A (1111395); 2214149-2, 00000005560M28 (IQ1394MR01); N/A, N/A (RADNETMRM01); 46-294231G1, 002005-0627-18 (ALLIANCESIG421); 46-294231G1, 0000099-0125-9 (907276ARMR); N/A, N/A (6444MRDICO); N/A, N/A (2809956); 46-294231G1, 0000001-0215-1 (INSIGHTMR1915); 2226300, 000000000R6838 (623445MR1); 2377062-2, 00000943572YM8 (201632MR); 46-294231G1, 0002002-0510-7 (ALLIANCESIG474); 46-294231G1, 002002-0125-22 (559585CCICMR2); 46-294231G1, 002002-0405-12 (205783TSMR);  5127452, 000000HDMR5415 (850484OMRI); 5308573, 00000300970MR1 (RADNETMR507); 5127452, 00000HDMR10886 (916423MR); 5127452, 000000HDMR3674 (501370CHMR); 5107849, 00000269580MR7 (PL3040MR01); 46-294231G1, 002004-1209-10 (YM1260); 2395001-2, 00000284023MR9 (083027002101567); 46-294231G1, 0000007-403-15 (083027802000517); 5127452, 000000HDMR5483 (1063THDX); 5127452, 000000HDMR3964 (SA1001MR03); 2395001-2, 00000280672MR7 (00440MRS02); N/A, 000000HDMR5233 (110037MR02); 5127452-3, 00001012BD66E0 (083027000143110); 2358431, 00000000WB0607 (AZ4013MR01); 5127452-3, 00001009BD6557 (BA4080MR01); 5308573-2, 00000299495MR2 (MRWB0540); N/A, N/A (5606MRS3T); 5127452-3, 00001009BD65F2 (083027009445910); N/A, N/A (773665MR3T); 5127452-3, 00001009BD6579 (2887688HDXT30T); 5127452, 00000275305MR1 (831423MR); N/A, N/A (2558948); 46-294231G1, 0002005-0607-4 (7067213TMR); 5127452-3, 000S0933BD5DFD (719542MR); N/A, 002003-0912-12 (DK1047MR04); 5127452, 000000HDMR5406 (0910273033); 5127452, 000000HDMR2642 (0850270218); 5421824-2, 00000310388MR4 (083027240009214); 2377062-2, 00000963651YM5 (IL1194MR01); 46-294231G1, 002005-1020-29 (HBLUCOMR01); N/A, 002004-0917-02 (00473MRS01); N/A, N/A (MR4013522); N/A, N/A (2679752); N/A, N/A (2541440); 2226300, 000000000R1733 (MRR1733); 2226300, 0000000000R273 (MRR273); 46-294231G1, 000099-0205-11 (0910272023);  N/A, N/A (PL1681MR01); N/A, N/A (H4443MR04); 5308573, 00000301741MR5 (MRR8267); 5308573, 00000301223MR4 (2918179MR); 2214149-2, 00000002339M20 (MRR8325); 2214149-2, 00000003155M29 (MRR8701); N/A, 000096-0126-27 (A020MR02); N/A, 00000175300MR3 (10079MRM42);  N/A, N/A (5272MRSIGNA4X); 2226300, 000000000R5436 (DEN00700);  2226300, 000000000R6601 (CE165329); N/A, N/A (0910273026);  46-294231G1, 002002-1126-23 (082427100148); 5308573, 00000300700MR2 (DEN00933); 46-294231G1, 000099-0122-13 (YE600210); 5127452, 000000HDMR5250 (DZ1009MR02); 2226300, 000000000R3823 (CS1275MR02); 2226300, 000000000R2680 (ZA2159MR02); 2214149-2, 00000014057GQ4 (082427030054); 2226300, 000000000R5680 (082427130073); 46-294231G1, 002005-1201-30 (HU1039MR03); 2226300, 000000000R6212 (DK1306MR02); 2214149-2 ,00000007668M27 (082427280013); 5308573, 00000301498MR2 (082427240016); 2226300, 000000000R7667 (082427050024); 5308573, 00000301500MR5 (MRR8257);  2226300, 000000000R6024 (CS1020MR01); 5308573, 00000291246MR7 (2761886); N/A, 000000000R6222 (2726027); 5308573, 00000301383MR6 (082427030063); 2226300, 000000000R7426 (082427100239); 46-294231G1, 002001-0718-35 (0910273020); 5308573, 00000301264MR8 (082427030061);  2226300, 000000000R6289 (082427160057); 2226300, 000000000R6200 (MPX19700); 2226300, 000000000R7028 (082427210051); 2226300, 000000000R6582 (DZ1259MR01); 2226300, 000000000R5895 (SA1129MR02); 2226300, 000000000R6955 (2807539); 2226300, 000000000R5724 (PPS18202); 2226300, 000000000R5733 (RU1550MR01);  2226300, 000000000R6139 (BG4538MR01); 2226300, 000000000R6439 (RU1279MR01); 2226300, 000000000R5352 (GE1004MR01); N/A, 000000000R6511 (2767032); 2214149-2, 00000004486M27 (082427080033);  2226300, 000000000R6806 (082427040088); 2226300, 000000000R5120 (0910273030); 2226300, 000000000R7718 (082427250022); 2226300, 000000000R5579 (RU1067MR02); N/A, N/A (082427040098);  5421824-2, 00000310944MR4 (082427080047); 2226300, 000000000R7870 (MRR7870); 46-294231G1, 000099-0817-11 (MPX47002); 5308573, 00000298557MR0 (0853270042IB1); 5421824, 00000311257MR0 (082427190081); 2214149-2, 00000002805M20 (082427040129); 2226300, 000000000R7050 (UPW00400); 2226300, 000000000R7884 (NPV85600); 2214149-2, 00000002750M28 (CS1338MR01); 2226300, 000000000R7342 (082427030049); 2214149-2, 00000003393M26 (RU1031MR01); 2226300, 000000000R7130 (CS1319MR01); 5127452-3, 00001012BD66A2 (0853270074IB1); 46-294231G1, 0002005-1201-2 (082427120126);  N/A, N/A (082427160098); 46-294231G1, 0000099-0414-7 (CP223906);  N/A, 000000000R3618 (BG4641MR01); 46-294231G1, 002002-1030-14 (H3943MR01); 46-294231G1, 002001-1018-36 (ZA2103MR01); 2214149-2, 00000005509M25 (082427230084); 5421824, 00000311572MR2 (082427140132); 5269997-9, 00000015025YR0 (0828270033); 2226300, 000000000R5260 (082427030103); 46-294231G1, 0000095-1120-5 (RU1089MR01); 5421824, 00000311574MR8 (082427230107); 2377062-61, 00000011084YR1 (27008MRS01); 2214149-2, 00000003870M23 (RU1457MR01); 5127452-3 ,00000838BD4ECB (35062MRS02); 7849-2, 00000283036MR2 (55027MRS01); 2395001, 00000285169MR9 (JO4109MR01); 5421824-2, 00000311280MR2 (082427230097); 507849-2, 00000288588MR7 (DK1393MR01); 2214149-2 , 00000007860M20 (082427210142MM3); 2214149-2, 00000004304M22 (H2294MR07); 2226300, 000000000R7091 (48021MRS01); 2214149-2, 00000004492M25 (KA2839MR01); 2214149-2, 00000003509M27 (RU1173MR01);  2226300, 000000000R3065 (082427160161); N/A, N/A (570844HCM3T);  5127452, 000000HDMR3447 (DPM32124); 5421834-2, 00000311145MR7 (082427130084); 5127452-3, 00000919BD5BB7 (082427220041); N/A, N/A (082427120070); 5127452, 000000HDMR1125 (082427040073); 2395001-2, 00000275466MR1 (DEN51500); 5127452, 000000HDMR5758 (082427040092); N/A, 0000000HDMR357 (CS1006MR03); 5127452, 000000HDMR1900 (0910274020); 5127452-3, 00001003BD640C (082427080026); 5127452-3, 00000938BD5F17 (082427190069); 5127452, 00000275290MR5 (DPC79014); N/A, N/A (082427100192); 5308573-2, 00000299275MR8 (082427200036); 5127452-3, 00001012BD66E1 (PER08626); 5127452-3, 00001003BD640D (PER28007); 5127452-3, 00000938BD5F14 (RO1189MR01); 5127452, 000000HDMR6035 (082427140120); 5107849-3, 00000302786MR9 (MRJ061); N/A, 00000293706MR8 (NPV58000); N/A, N/A (0910276003); N/A, N/A (626570MR); N/A, N/A (907561AIMR); N/A, N/A (309451MR); 46-294231G1, 000002-1003-15 (201967MR); 2226300, 000000000R5771 (0853270133GS);  46-294231G1, 0000099-0521-6 (ALLIANCESIG85); 2377062-61, 00000011265YR6 (MRR6469); N/A, N/A (083027067005818); N/A, N/A (520GVHMR); N/A, N/A (2939576HDXT); N/A, N/A (520872MR); 2226300, 000000000R1970 (H10650MR08); 2226300, 000000000R6733 (A197998701);  2226300, 000000000R6448 (0828270030); 2214149-2 , 00000015124GQ1 (0834270011); N/A, 002000-0907-10 (CPM80615); 5127452, 000000HDMR5960 (0834270010); 5127452-3 , 00001009BD6578 (0834270015); 46-294231G1, 000096-0126-15 (YP630007); 2226300, 000000000R6352 (YP600200); 2226300, 000000000R2306 (RU1086MR01);  46-294231G1, 0002002-0506-3 (FEC80061); 2377062, 4337424 (MEX34410);  5127452, 000000HDMR4309 (UPW28900); 2395001, 00000280327MR8 (UPW21605); 2226300, 000000000R5291 (YP601000); 46-294231G1, 002000-0426-18 (0856270029); 46-294231G1, 0000099-0722-1 (ME208331);  2226300, 000000000R4276 (FPF35809); 46-294231G1, 002004-1117-12 (0828270020IB01); N/A, 00000001400M21 (NPV84508); 2377062-61 , 00000011251YR6 (MEX71105); 2395001, 00000283516MR3 (MP118825);  46-294231G1, 002003-1027-20 (A5103135); 5396469-2, 00000310306MR6 (NO1005MR02); 46-294231G1, 0000095-0810-3 (A5278401); 46-294231G1, 002003-0903-12 (A5111732); 2226300, 000000000R4164 (A5684809);  2226300, 000000000R6773 (PER08305); 2226300, 000000000R6502 (2766544); 2226300, 000000000R5403 (H1063MR18); 2226300, 000000000R5912 (H1420MR14); 46-294231G1, 002002-0809-08 (CPZ09609);  46-294231G1, 002003-0708-01 (PER00417); 46-294231G1, 002000-1013-15 (A5632405); 2214149-2, 00000002229M23 (MRR8295); 2226300, 000000000R2375 (A5745509); N/A, N/A (0853270100); N/A, N/A (083027100973317); N/A, 002002-0814-05 (H1066MR16); 46-294231G1, 000093-0528-15 (DE528434); 2226300, 000000000R7136 (0910272086);  2395001, 00000280778MR2 (0843270015); N/A, N/A (0910274013);  46-294231G1, 0000098-0608-5 (0910272020); 2395001, 00002835171MR1 (083027040006015); 2226300, 000000000R6574 (2767673); 2226300, 000000000R5159 (3882647967MROCC); 46-294231G1, 0002005-0331-3 (H12041MR02); 46-294231G1, 0000000MRU0407 (IE1025MR01);  2226300, 000000000R3756 (PVIL01MR01); 46-294231G1, 000097-1107-10 (PNUE01MR03); 46-294231G1, 002005-0823-17 (HPAD01MR01); N/A, N/A (PL1774MR02); 2226300, 000000000R6092 (0859270002); 2226300, 000000000R6021 (0859270001); 5127452, 000000HDMR1019 (RU3023MR01); N/A, 000000HDMR5374 (PM1633MR03);  2226300, 000000000R4692 (PL1704MR01); N/A, N/A (083027242000437);  2226300, 000000000R1663 (PC0976MR01); 46-294231G1, 0002001-0323-1 (MA1152MR01); 46-294231G1, 0000095-0912-5 (PX2261MR02); 5127452, 1529759 (MC6946MR07); 2395001-2, 00000278549MR1 (RU1127MR02);  46-294231G1, 000006-0523-10 (RU1834MR01); 5127452, 3877 (00240MRS01); 46-294231G1, 002000-0816-10 (PC0396MR03); 46-294231G1, 0000098-0528-5 (A5566913); 5127452, 000000HDMR2483 (A171995610); 2226300, 000000000R2753 (DK1343MR01); 2226300, 000000000R6499 (A5192410); N/A, 000000000R7233 (1324655); 5308573, 00000302145MR8 (MRR8303); 2226300, 000000000R6460 (22MRHDX2762068); 2226300, 000000000R5214 (H17641MR12);  N/A, 02001-12210-13 (A042MR01); 2226300, 000000000R7197 (2835341HDX); 2395001-2, 00000286650MR7 (H2193MR05); 2226300, 000000000R6520 (A51273121); 2226300, 000000000R2396 (MRR2396);  46-294231G1, 000007-0530-16 (UK28); 46-294231G1, 000097-0331-10 (DK1029MR01); 2214149-2 , 00000009304M27 (MRR8592); 2320288, 00000096546WH7 (10695MRM01); 2226300, 000000000R2753 (DK1394MR01); 2357500, 00000249262MR7 (16683THDX); 2226300, 000000000R7564 (A5146405); N/A, N/A (650742KSSFMR); 46-294231G1, 0000096-0419-4 (0920279006); N/A, N/A (916SRFMR); N/A, N/A (7366);  46-294231G1, 002002-0517-19 (IR1026MR01); N/A, N/A (0847270018);  46-294231G1, 0000099-0329-4 (A5127353); N/A, N/A (0847270025);  46-294231G1, 002001-1018-32 (PC7425MR01); N/A, 000000000R1116 (AH4511MR02); N/A, N/A (843549MR); 2226300, 000000000R1533 (LLS0120); 5308573, 00000293870MR2 (CC0820MR10); 46-294231G1, 002004-0713-22 (393115MR01); N/A, N/A (00200MRS03); N/A, N/A (ALLIANCESIG270); N/A, 0002000-1102-1 (DK1042MR01); 46-294231G1, 002004-0206-15 (397480MR01); N/A, N/A (707571KSRMR); N/A, N/A (8183MRLX); 2377062-2, 00000951076YM9 (805687MR2); 2226300, 0000000000R575 (HC1770MR01 ); N/A, N/A (A5183710); N/A, N/A (585786MRI); 2226300, 000000000R6712 (0847270023); 2226300, 000000000R5610 (0843270017); 46-294231G1, 002002-0315-13 0847270001); 46-294231G1, 0002000-0301-4 (SA1012MR01); N/A, N/A (570844TWINSPEED); N/A, N/A (422SIGNA15); N/A, 002000-1221-14 (DK1047MR03); 46-294231G1, 002003-0929-03 (N4192928); N/A, N/A (0910274008); 46-294231G1, 002003-0818-13 (34026MRS03); N/A, 00000275019MR8 (35045MRS03); 2226300, 000000000R5050 (082427130074); N/A, 00000310642MR4 (082427130082); 5421824, 00000311573MR0 (082427180036); 5453862-2, 308735MR0 (082427240048);  N/A, N/A (PL3331MR01); N/A, N/A (409637LX1); N/A, N/A (618798SMR).  
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
FDA Determined
Cause 2		 Software change control
Action The firm, GE Healthcare, notified its customers on or before 06/07/2018 via a letter entitled "URGENT MEDICAL DEVICE CORRECTION". The letter described the product, problem and actions to be taken. The letter informed customers that GE Healthcare will inspect all affected systems and ensure the proper software version is installed. Instructions for customers to confirm the current software included the following steps: 1. Click on tools icon located on the top left of the screen; 2. Click on Service Browser Button; 3. The MR Service Desktop browser will launch (may take 1 minute to launch); 4. Look at the Release Information on the screen and compare both MrpApps Build Number and Service Pack Build Number on the screen to two tables provided in the safety issue section of the customer letter. If you have identified that your system has invalid software version, please contact GE Healthcare service representative immediately. GE Healthcare will advise you after your software version has been inspected and inform you if any correction is needed. If a correction is needed, a service representative will contact you to arrange for this correction. Questions or concerns regarding this notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 5,200 total units
Distribution Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and countries of: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, CYPRUS, Czech Republic, DENMARK, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Portugal, Puerto Rico, Russia, Saudi Arabia, SINGAPORE, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC
510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.
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