GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SI...
FDA Device Recall #Z-0111-2019 — Class II — June 7, 2018
Recall Summary
| Recall Number | Z-0111-2019 |
| 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 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E
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) : 2226300, 000000000R4938 (256329MR2); 2226300, 000000000R5598 (256ALOPMR); N/A, N/A (334699MR); 2377062-2, 00000002547YR8 (256265HMR); 5107849, 00000274691MR5 (205487MR2); 46-294231G1, 0002005-0411-5 (870972E16); 46-294231G1, 002005-1201-35 (623583MR1); 2377062-2, 00000963660YM6 (480323MR1); 5107849-2, 00000278561MR6 (818445MR); 46-294231G1, 002004-1028-04 (3825); 2377062, 00000941225YM5 (626335MR); 46-294231G1, 002004-0913-01 (3591); 46-294231G1, 002005-1018-15 (352333MR3T); N/A, N/A (954587MR1); 46-294231G1, 002002-0605-11 (781340MR); 5107849, 266201MR3 (RADNETMR1585); 46-294231G1, 002005-0110-28 (313593MR02); 5308573, 00000292781MR2 (609890MR); 2214149-2, 00000010224GQ4 (732745MR); 2377062-2, 00000963098YM9 (607798MREXCT); N/A, N/A (516825MR); N/A, N/A (405307NMR); N/A, N/A (814535MR1); 5107849-2, 00000283624MR5 (615588MRI); N/A, N/A (615473MR1); N/A, N/A (817922MRLX); 5107849-2, 00000278623MR4 (972378NSC3TMR1); 46-294231G1, 0002005-0823-7 (DZ1057MR01); 46-294231G1, 002006-0127-10 (DZ1193MR01); 2226300, 00000000R5456A (2722SIGNA15); 2226300, 000000000R6230 (4291EXC15T); 2226300, 000000000R4601 (MRR4601); 2226300, 000000000R4973 (0910272001); 2226300, 000000000R5899 (0910274027); M3000PT, 00000280570MR3 (0910273001); 46-294231G1, 002005-0511-13 (AZ1003MR01); 46-294231G1, 0000099-0111-2 (110037MR01); 46-294231G1, 002005-0301-06 (2560124); 2226300, 000000000R5054 (BA4073MR01); N/A, 000000000R6295 (2712857); 5308573, 00000290734MR3 (2771768); 2226300, 000000000R6853 (2776713); 5107849-2, 00000284596MR4 (1236631); 2226300, 000000000R5190 (1191369); N/A, N/A (270004); 2189500-3, 00000201911MR5 (22946-1); 46-294231G1, 002005-0301-18 (CATMR01); 46-294231G1, 000005-1212-11 (CRMR01); 2226300, 000000000R5504 (082427310017); 2215261, 00000215559MR6 (082427040057); 2226300, 000000000R5271 (082427040072); N/A, 00000243366MR2 (082427040040); 46-294231G1, 0000003-0315-2 (082427040061); 2226300, 000000000R6344 (082427040074); 5107849-2, 00000289798MR1 (082427100093); 5107849-2, 00000283174MR1 (082427140047); 5107849-2, 00000282831MR7 (082427140046); 5107849-2, 00000283662MR5 (082427210041); 5107849-2, 00000282959MR6 (2697548EXCITE); 2226300, 000000000R5692 (2694100HD); N/A, N/A (CY1028MR01); 2226300, 000000000R4124 (PC0114MR03); 46-294231G1, 000006-0425-19 (HC4719MR02); 5107849, 00000272346MR8 (CC5340MR02); N/A, 0002005-1020-4 (126597MR01); 46-294231G1, 0002005-0511-6 (125390MR01); 46-294231G1, 000091-0919-12 (PSTU02MR01); 2226300, 000000000R5851 (2704833SIGNA); N/A, 000000000R5205 (GF1002MR01); 2226300, 000000000R4942 (24527633818MRI); 46-294231G1, 002005-0519-10 (0828270022IB01); 46-294231G1, 002005-0216-12 (0828270021IB01); N/A, 0000006-0323-2 (HU1099MR01); 5107849-2, 00000284297MR9 (083027062101067); 5107849, 00000267657MR5 (083027826593614); 46-294231G1, 000007-0530-11 (083027592002490); N/A, N/A (083027062101391); 2226300, 000000000R5902 (083027602101557); N/A, N/A (0835270007); 2108800-2, 535779 (B5174306); 46-294231G1, 0002005-0714-6 (A126322002); N/A, N/A (B5183714); 2226300, 000000000R5542 (B5367312); 2377062-2, 00000963588YM9 (A6118004); N/A, N/A (A148761302); N/A, 00000189273MR6 (A5155133); 2226300, 000000000R5739 (A377686701); 2226300, 000000000R5390 (A6134706); 46-294231G1, 002001-0702-56 (A5104397); 2357500-3, 00000300710MR1 (A5739706); 46-294231G1, 002005-0805-20 (YM1503); 2226300, 000000000R4952 (YM1516); 2198999-2, 00000158807MR8 (YM0451); N/A, 000000000R4216 (JO1029MR01); 2226300, 000000000R1382 (0850270404); N/A, 00000271322MR0 (0850270094); 5107849, 00000282503MR2 (LV4038MR01); 46-294231G1, 0002005-1130-3 (1084MREINP); 5107849, 00000263976MR3 (MR262474MR0); 2377062-2, 00000963560YM8 (5606SIGNA); 46-294231G1, 002005-0411-13 (56MRE3TH2565370); 2226300, 000000000R5911 (813EXCITEHD); 2226300, 000000000R5037 (2640781MR-1); 2226300, 000000000R5966 (99251SIGNAHD); 46-294231G1, 000006-0403-14 (99201MR15); 2395001-2, 00000280669MR3 (0920279025); 46-294231G1, 0000099-0722-5 (0920279011); N/A, N/A (25565916MR); 2226300, 00000000R4926A (PL1530MR02); 46-294231G1, 000006-0308-13 (787740MOBILE); 5107849, 00000276591MR5 (787653MR3T); 46-294231G1, 0000006-0315-5 (787840CIRT3T); 46-294231G1, 002001-0530-30 (787840EXCITE); N/A, 000000000R5552 (RO1115MR01); 2226300, 000000000R5057 (RU1195MR01); 46-294231G1, 002005-1212-26 (600130MR02); 5107849, 00000275845MR6 (RU1283MR01); 46-294231G1, 000006-0412-16 (RU1296MR01); 2226300, 000000000R5862 (SA1014MR02); 2226300, 000000000R5545 (SA2051MR01); 2226300, 000000000R5699 (SA1041MR02); 46-294231G1, 002005-0328-20 (SA1004MR02); N/A, 002005-1018-11 (SA1006MR02); 2226300, 000000000R5764 (SA1021MR01); 2226300, 000000000R4655 (0847270017); 46-294231G1, 002005-1201-14 (ZA1180MR01); 2226300, 000000000R5102 (NPV31703); 2226300, 000000000R4415 (MPX33111); 2357500-2, 00000265818MR5 (MPX49302); 5107849, 00000275642MR7 (GEE34040); 2357500-2, 00000265818MR5 (MPX94700); 5107849, 00000278210MR0 (UPW21613); 2377062-2, 00000963343YM9 (DPI53205); 5107849, 00000267036MR2 (DPN62300); 46-294231G1, 0000094-0131-5 (DPM19607); 46-294231G1, 0000005-0209-1 (FPG33602); 5127452, 00000VALUE1177 (NPV77700); N/A, 002005-0627-13 (387040MR06); 2357500, 00000259106MR3 (0853270052IB1); N/A, N/A (0853270070); 46-294231G1, 0002005-0519-8 (0856270035); 2226300, 000000000R4976 (0856270037); N/A, N/A (0856270042); 5107849-2, 00000279892MR4 (06108MRS01); 46-294231G1, 002005-1201-26 (34006MRS03); 46-294231G1, 000006-0502-12 (35045MRS01); 2226300, 00000000R4866A (78004MRS01); N/A, N/A (45007MRS01); 5107849, 00000266746MR7 (54014MRS01); 2226300, 000000000R5885 63025MRS01); 2226300, 000000000R5892 (UK1015MR02); N/A, N/A (00133MRS02); N/A, N/A (05270MRS01); 46-294231G1, 002002-0221-13 (70065MRS02); 5107849-2, 00000280006MR8 (10079MRM73); 46-294231G1, 0000006-0511-7 (3882630908MRMET);
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.