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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare MRI Systems, Software Version 11.x

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  Class 2 Device Recall GE Healthcare MRI Systems, Software Version 11.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-0110-2019
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 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
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). 
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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