GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5...
FDA Device Recall #Z-0110-2019 — Class II — June 7, 2018
Recall Summary
| Recall Number | Z-0110-2019 |
| 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 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE, 1.5T SIGNA EXCITE MRI, 1.5T SIGNA VIBRANT 16CH FIXED, 3.0T MRI TWINSPEED 8CH, 3.0T SIGNA EXCITE FIXED, 3.0T SIGNA EXCITE UPGRADE, 3T EXCITE, EX ES+8CH USED EXCITE, EXCITE 1.5T, EXCITE 3.0T, EXCITE TWIN, GOLDSEAL 1.5T EXCITE 4CH, GOLDSEAL 1.5T EXCITE 8CH, GOLDSEAL 1.5T EXCITE REL GOLDSEAL EXCITE 1.5T, GOLDSEAL EXCITE 1.5T 8CH, GS 1.5 EX ES+ 4CH NEW, GS 1.5 EX ES+4CH USED, GS 1.5 EX ES+8CH NEW, GS 1.5T EXCITE MRI, GS CLASS 1.5T ES+ EX 4CHN, GS SIGNA EXCITE II 1.5T, GS SIGNA MR/I 1.5T, LCC EXCITE 1.5T, MR 1.5 EX ES 8CH NEW, MR 1.5 EX ES+ 4CH, MR 1.5 EX ES+4CH MOB, MR 1.5 EX ES+8CH, MR 1.5EX8CH, MR 1.5EX8CH USE -HUNG, MR 1.5T EX8CH, MR 1.5T EXCITE 4CH, MR 1.5T EXCITE EXPERT MR, MR 1.5T EXCITE GS, MR 1.5T EXCITE GS MR, MR 1.5T GS ES+ EXCITE 4 CHANNE, MR 1.5T SIGNA EXCITE 8 CH GOLD SEAL, MR 1.5T SIGNA EXCITE II 4CH, MR 3.0T TWINSPEED, MR 3.0T SIGNA EXCI, MR 3.0T SIGNA EXCITE, MR 3.0T SIGNA EXCITE FIXED, MR EXCITE, MR EXCITE 1.5T, MR EXCITE 3, MR EXCITE ECHOSPEE, MR EXCITE ECHOSPEE UPG, MR EXCITE ECHOSPEED, MR EXCITE HISPEED MR EXCITE TWINSPEE, MR EXCITE TWINSPEED, MR GOLD SEAL 1.5 EX ES+8CH NEW, MR GOLDSEAL 1.5 ES PL EX 4 CH, MR GOLDSEAL 1.5 EX, MR GOLDSEAL 1.5 EX, MR GOLDSEAL 1.5 EX 4CH, MR GOLDSEAL 1.5 EX 8CH, MR GOLDSEAL 1.5 EX ES+ 4CH, MR GOLDSEAL 1.5 EX ES+ 4CH NEW, MR GOLDSEAL 1.5 EX ES+4CH, MR GOLDSEAL 1.5 EX ES+4CH USD, MR GOLDSEAL 1.5 EX ES+4CH USE, MR GOLDSEAL 1.5 EX ES+4CH USED, R GOLDSEAL 1.5 EX ES+8CH, MR GOLDSEAL 1.5 EX ES+8CH NEW, MR GOLDSEAL 1.5 EX ES+8CH USED, MR GOLDSEAL 1.5 EXCITE S+ 4CH, MR GOLDSEAL 1.5 FIXED ACTIVE, MR GOLDSEAL 1.5EX4CH NEW -HUNG, MR GOLDSEAL 3.0T EXCITE HD FIX, MR GS 1.5 EX, MR GS 1.5 EX ES+8C, MR GS 1.5 EX ES+8CH, MR SIGNA 1.5 EXCIT, MR SIGNA 1.5 EXCITE EXPERT, MR SIGNA 1.5T EXCITE, MR SIGNA 1.5T EXCITE 4CH MR SIGNA 1.5T EXCITE 8CH, MR SIGNA 1.5T EXCITE 8CH MOBIL, MR SIGNA 1.5T EXCITE EXPERT, MR SIGNA 1.5T EXCITE II, MR SIGNA 15T EXCITE 8CH, MR SIGNA 15T EXCITE 8CH MOBIL, MR SIGNA EXCITE 1.5 T GS (4 CHANNEL, MR SIGNA MR/I ECHOS W/EXCITE, MR SIGNA MR/I ECHOSPD W/ EXCITE, MR SIGNA MR/I ECHOSPD W/ EXCITE , MR SIGNA MR/I ECHOSPEED W/ EXCITE, MR SIGNA MR/I HISPEED W/ EXCITE MR SIGNA MR/I TWISP TR W/EXCIT, MR TWINSPEED 1.5T W/ EXCITE, MR UPG 1.5 SIGNA LX TO EXCITE, MR UPG 3.0T94 ECLIPSE TO EXCIT, MR/I ECHOSPD W/ EXCITE, MR/I ECHOSPEED W/ EXCITE, MR/I SIGNA ECHOSPD W/ EXCITE, MRI EXCITE, MRI EXCITE 1.5T FIXED, MRI SIGNA EXCITE 1.5T, PREOWN 1.5T EXITE, SIGNA 1.5 EXCITE, SIGNA 1.5T , CHOSPEED W EXCITE, SIGNA 1.5T ECHOSPEED W/EXCITE, SIGNA 1.5T ES EXCITE, SIGNA 1.5T EXCITE, SIGNA 1.5T EXCITE 2, SIGNA 1.5T EXCITE EXPERT, SIGNA 1.5T EXCITE II, SIGNA 1.5T SMART SPEED, /EXCITE, SIGNA 1.5T W/ EXCITE, SIGNA 3.0T E, SIGNA 3.0T SIGNA EXCITE FIXED, SIGNA ECHOSPEED 1.5T FIXED, SIGNA ECHOSPEED EXCITE 1.5T, SIGNA ECHOSPEED LX 1.5T FIXED SIGNA ECHOSPEED PLUS + EXCITE, SIGNA EXCITE, SIGNA EXCITE 1.5 SIGNA EXCITE 1.5 T HISPEED, SIGNA EXCITE 1.5T, SIGNA EXCITE 1.5T RELEASE 12.X/MR, SIGNA EXCITE 1.5T SMART SPEED, SIGNA EXCITE 11X, SIGNA EXCITE 3.0T, SIGNA EXCITE ECHOSPEED 1,5 T, SIGNA EXCITE ECHOSPEEED PLUS 1.5 T, SIGNA EXCITE EXPERT 1.5T, SIGNA EXCITE GS 1.5T 4 CHANNEL,SIGNA EXCITE II, SIGNA HISPD LX K4 1.5T FIXED, SIGNA HORIZON LX 1.5T FIXED, SIGNA LX 1.5 EXCITE II., SIGNA LX 1.5T EXCITE, SIGNA LX 1.5T EXCITE II, SIGNA LX1.5T HISPEED, SIGNA MR 1.5 ES EXCITE, SIGNA MR/I 1.5T EXCITE, SIGNA MR/I ECHO W/E,SIGNA MR/I ECHOESPEED W/EXCITE, SIGNA MR/I ECHOSPD, SIGNA MR/I ECHOSPD 1.5T FIXED, SIGNA MR/I ECHOSPD W/ EXCITE 1.5, SIGNA MR/I ECHOSPEED W/ EXCITE, SIGNA MR/I ECHOSPEED W/ EXCITE 1.5T, SIGNA MR/I ECHOSPEED W/EXCITE, SIGNA MR/I ECHOSPEED WITH EXCI, SIGNA MR/I ECHOSPEED WITH EXCITE SIGNA, MR/I
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, 002003-0530-08 (GOLD010252), 46-294231G1, 002004-0406-06 (HC5300MR02), 46-294231G1, 000004-0311-16 (IE1053MR01), 2377062-2, 00000963562YM4 (0850270477), 2377062, 00000983439YM5 (0850270470), 46-294231G1, 002002-1021-51 (0850270122), 46-294231G1, 0000099-0809-8 (482180SIGNA), 2377062, 00000941219YM8 (561863MR1), N/A, N/A (0910272059), 2226300, 000000000R1040 (PL1124MR02), N/A, 0002005-0922-4 (00491MRS01), N/A, N/A (083027200000913), 2377062-2, 963531YM9 (559713CMIMR), 7452, 000000HDMR6133 (IE1111MR01), 46-294231G1, 002004-1028-17 (2059393T), N/A, 002004-0823-18 (M4135138); 46-294231G1, 002004-1115-13 (0850270170); 46-294231G1, 04 0211-4 (912354MRI); 46-294231G1, 002004-1109-02 (44EXCITE2550834); 46-294231G1, 002004-0913-16 (YM4157); 46-294231G1, 002005-0914-20 (YM1414); 46-294231G1, 002003-0708-02 (YM2028); 2226300, 0000000R7722 (1337081); 2377062-2, 00000951060YM3 (MRR7674); 2226300, 000000000R3880 (083027602171311); 2357500-2, 00000268322MR5 (MRR0455); 2214149-2, 00000006147M23 (1347499); 2377062-2, 00000956341YM2 (2682089); 2357500-2, 00000281517MR3 (2641178); 2226300, 000000000R5825 (2682131); 2377062-2, 00000963279YM5 (083027846014410); 2226300, 000000000R5837 (1238483); 2226300, 000000000R5419 (48MRE2744667); N/A, N/A (299SIGEXC); N/A, N/A (H1787MR11); 2226300, 000000000R7325 (2850446); 2226300, 000000000R7402 (PPR94108; 2357500-2, 00000272881MR4 (UPW21614); 2377062-2, 00000963044YM3 (MPX39916); 2377062, 00000962662YM3 (A5912915); 2377062-2, 00000002522YR1 (YP567303); 2377062, 00000941242YM0 (FPG23603); 2226300, 000000000R7543 (FPG84701); 2377062, 00000951821YM8 (1292548); 2377062, 00000962780YM3 (2713328); 2226300, 000000000R6610 (2762011); N/A, 000000000R5956 (1238481); 2226300, 000000000R4173 (MRR4173); 2357500-3, 00000298377MR3 (PPR67317); 5127452, 000000HDMR5690 (CEN03406); 46-294231G1, 0002005-1109-4 (0853270072); 46-294231G1, 002004-0830-13 (082427040042); 46-294231G1, 002004-0830-10 (082427230015); N/A, N/A (083027600255513); 5139394-2, 00000006184YR6 (082427040067); 46-294231G1, 000006-0511-18 (7771MREXCITE3); 2357500-2, 00000254491MR4 (082427040056); N/A, 00000309690MR6 (082427160133); 2226300, 000000000R5262 (082427100072); 2226300, 000000000R4812 (082427160046); 2294302, 00000249253MR6 (082427130020); 2226300, 000000000R3913 (082427040044); 2226300, 000000000R7983 (MRR7983); 2226300, R1698 (678324MR); 2226300, 000000000R2220 (083027861003910); 2226300, 000000000R1928 (083027062176711); 2357500-3, 00000299538MR9 (ILSMR1); 2357500-3, 00000299960MR5 (MRR8022); 2357500-2, 00000282641MR0 (H17659MR1); N/A, N/A (205206MR1); 2357500-3, 00000298579MR4 (MRR8015); 2214149-2, 00000002656M27 (MRR8481); 2357500-3, 00000297885MR6 (771MR2891120); N/A, N/A (479936MRHOG); 2357500-3, 00000299516MR5 (MR259430MR7); N/A, N/A (928699MR); N/A, N/A (907VNSMR); 2226300, 000000000R5752 (RO1121MR01); N/A, N/A (916733MR2); 2214149-2, 00000002639M23 (MRR8461); 5122373-2, 00000086257DP3 (901516U3T); 2214149-2, 00000002793M28 (L2770MR01); N/A, N/A (083027002824690); 2214149-2, 00000002043M28 (PL3677MR01); 2377062-2, 00000963601YM0 (082427010016); 2226300, 000000000R6529 (PPR29305); 2357500-2, 00000258396MR1 (PPR10411); 2377062-2, 00000956334YM7 (UP389021); 2226300, 000000000R2739 (NPV89300); 2284300, 00000276193MR0 (UPW21611); 2377062-2, 00000943593YM4 (2709088); 2226300, 000000000R3694 (PER28125); 2189500-3, 00000204698MR5 (MP118827); 2226300, 000000000R4458 (FPG11803); N/A, 000000000R6087 (H17661MR01); 46-294231G1, 002003-0320-09 (FEG45915); N/A, 0002005-0725-8 (PPR47506); 2377062, 00000962577YM3 (0853270061); 2189500-3, 00000206006MR9 (RU3408MR01); 2284300, 00000253648MR0 (34148MRS01); 46-294231G1, 002005-0927-23 (0853270074); 46-294231G1, 0002003.111.06 (5606TWEX); N/A, N/A (082427140023); N/A, 00000254375MR9 (NPV26104); 46-294231G1, 002003-0915-23 (FPG13900); N/A, 00000963342YM1 (KE1000MR01); N/A, 000000000R4581 (B5387602); N/A, N/A (0910274031); 2377062, 00000951828YM3 (NPV24000); 46-294231G1, 002000-1003-14 (NP739709); N/A, N/A (083027598401216); 46-294231G1, 002003-0708-10 (0910273024); N/A, N/A (083027042101154); N/A, N/A (083027022100534); 46-294231G1, 000099-0223-10 (126292MR01); 2294302, 00000249254MR4 (2222EXITE); 2357500-2, 00000274050MR4 (2284SIG15T); 2377062, 00000962626YM8 (2774243SIGNA); 2377062-2, 00000963367YM8 (1228042-1); 46-294231G1, 000097-0929-12 (KW1007MR02); 46-294231G1, 000004-0311-15 (A5355209); N/A, 002004-0701-08 (409740MR01); 46-294231G1, 002005-0927-30 (0910272044); N/A, N/A (805648MR); N/A, 00001009BD655A (GOLD011048); N/A, N/A (209225VCMR); N/A, 002003-0320-18 (110807MR01); 2226300, 000000000R4130 (2564618SIGNA); 2226300, 000000000R3122 (MRR3122); 46-294231G1, 002005-0620-20 (H2135MR07); 2226300, 000000000R6040 (2672732SIGNA); 2226300, 000000000R6211 (2730910SIGNA); 2226300, 000000000R4428 (2585063SIGEX); 2226300, 000000000R3928 (A5769207); N/A, 002004-0406-16 (M4434864); 2226300, 000000000R5189 (H44432MR01); 2377062-2, 00000951044YM7 (H17660MR3); 2377062-2, 00000963349YM6 (4867SIGEXC1); 2226300, 000000000R5611 (H17658MR01); 46-294231G1, 002001-0904-14 (38880918MRCTR); N/A, N/A (504MCMR); N/A, N/A (205431MR1); 46-294231G1, 000000000R3717 (SY2012MR01); N/A, 00000010462GQ0 (GOLD10637M); 2226300, 000000000R1083 (GOLD0EU113); 2377062-61, 00000008358YR4 (GOLD0EU120); 46-294231G1, 0002002-0422-9 (A5162244); 46-294231G1, 002004-0830-12 (3882540976MRMET); N/A, N/A (441887MR01); 46-294231G1, 002004-0909-13 (2842546BEXCITE); N/A, N/A (083027202100984); N/A, N/A (626795MR); N/A, 000000000R5449 (GOLD011065); 46-294231G1, 0002005-0519-7 (EG1522MR01); 46-294231G1, 002004-1115-07 (06034MRS02); 46-294231G1, 002004-1130-12 (06166MRS01); 46-294231G1, 002005-0812-18 (RU2402MR01); 46-294231G1, 002005-0627-17 (HU1243MR01); 46-294231G1, 002002-1030-07 (INSIGHTMR1277); 2377062-2, 00000963389YM2 (619340MR1); 2294302, 00000241135MR3 (CC0820MR05); 46-294231G1, 0000099-0518-3 (HC0399MR01); 46-294231G1, 002004-0713-04 (SA1255MR01); N/A, 00000309602MR1 (RO4165MR01); 46-294231G1, 002003-1218-15 (RU2371MR01); 46-294231G1, 002004-1209-03 (34169MRS01); 2226300, 000000000R3948 (34421MRS01); 46-294231G1, 002003-1218-21 (RU2490MR01); 2226300, 000000000R3764 (RO1089MR01); 46-294231G1, 002003-0320-01 (225647MR); 2284300, 00000245980MR8 (242501602MR); 46-294231G1, 002004-0303-13 (ZA2119MR01); 2377062, 00000962741YM5 (770454EDMR); 2377062-2, 00000963075YM7 (INSIGHTMR1348); 46-294231G1, 002002-1204-07 (A5753803); 2226300, 000000000R2594 (A5761301); 46-294231G1, 002005-1003-16 (SA1022MR01); 2226300, 000000000R4200 (16041MRS03); N/A, N/A (38895718MRMET); N/A, N/A (225381MR); 2294302, 00000249260MR1 (53515EXCITE); 2214149-2, 00000009718M28 (BMALTA46); 46-294231G1, 002004-0416-11 (K3585); N/A, 0002002-0405-2 (MC6946MR05); 46-294231G1, 002001-0823-10 (0910274012); 2357500-2, 00000265611MR4 (11393838MR); 46-294231G1, 002003-0409-01 (ZTM0120); 2226300, 000000000R2823 (HU1530MR01); N/A, 00000310561MR6 (082427120138); 2377062, 00000962791YM0 (314644IMR1); 46-294231G1, 002003-1015-18 (941795MR); 46-294231G1, 002003-0530-15 (732493MR1); 46-294231G1, 0000098-0617-6 (501219AHMR); 2377062-2, 00000943653YM6 (PIKETWIN); 46-294231G1, 000098-0824-10 (719578MR).
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.