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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare MRI Systems, Software Version 12.x

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  Class 2 Device Recall GE Healthcare MRI Systems, Software Version 12.x 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-0111-2019
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 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
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);  
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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