CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
GE Healthcare MRI Systems recalled by GE Medical Systems
GE Medical Systems is recalling GE Healthcare MRI Systems, distributed nationwide in the US. The recall was initiated on 7 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0111-2019
- FDA event ID
- 80323
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2018
- FDA classified
- 15 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 7 Jun 2018 | Recall initiated by company | |
| 15 Oct 2018 | Classified by FDA | +130 days |
| 24 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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);
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 80323This product is part of a recall event; the main page for the event is GE Healthcare MRI Systems recalled by GE Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GE Healthcare MRI Systems recalled by GE Medical Systems | GE Medical Systems | Device Malfunction | Nationwide | |
| CLASS II | GE Healthcare MRI Systems recalled by GE Medical Systems | GE Medical Systems | Device Malfunction | Nationwide |
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