FDA Enforcement Class II Terminated

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

Recall: Z-0110-2019 · Reported October 24, 2018

Enforcement

Recall Number: Z-0110-2019
Event ID: 80323
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: GE Medical Systems, LLC
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: October 24, 2018
Initiation Date: June 7, 2018
Classification Date: October 15, 2018
Termination Date: June 18, 2020
Address: 3200 N Grandview Blvd, N/A, Waukesha, WI, 53188-1693, United States

Description

Reason

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.

Code Info

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).

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.

Quantity

5,200 total units