GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names:...
FDA Device Recall #Z-0112-2019 — Class II — June 7, 2018
Recall Summary
| Recall Number | Z-0112-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 7, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 5,200 total units |
Product Description
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
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.
Distribution Pattern
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.
Lot / 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).
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
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.