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U.S. Department of Health and Human Services

Class 2 Device Recall GE SIGNA Creator (1.5T) and SIGNA Explorer (1.5T) MRI systems

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  Class 2 Device Recall GE SIGNA Creator (1.5T) and SIGNA Explorer (1.5T) MRI systems see related information
Date Initiated by Firm August 31, 2016
Create Date September 02, 2016
Recall Status1 Terminated 3 on July 31, 2018
Recall Number Z-2731-2016
Recall Event ID 75081
510(K)Number K143251  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Code Information Mfg Lot or Serial # System ID MNEXP1600002MR 480425MR7 001709TA5 520ASRMR 003175TA7 916RAFMR 002448TA9 559449SPMR 002674TA0 559449SPMR 002027TA1 203337MREXP 003012TA2 GON: 4371049 002974TA4 239458MR1 003399TA3 239292MR1 002380TA4 305983MR3 002753TA2 727869MR 003356TA3 954473MR1 003176TA5 773843SCMR 000753TA4 574206MR 003013TA0 508746JMR2 003019TA7 417269MRS2 003371TA2 601853MR1 001027TA2 704384MINT 001059TA5 7 04384MINT 002453TA9 513569MR1 002741TA7 513584MR 001063TA7 254965CTOMR1 002879TA5 920560EXP 002831TA6 GON: 1532602 002023TA0 DZ1035MR03 002081TA8 DZ1863MR01 003302TA7 GON: 4399202 002742TA5 GON: 4374136 003076TA7 DZ1149MR02 003731TA7 DZ2014MR01 003079TA1 DZ1908MR01 003078TA3 DZ1174MR01 003565TA9 GON: 4345190 003134TA4 DZ1947MR01 002883TA7 83147183761 003174TA0 83140192745 003508TA9 83151589682 003403TA3 083027600486516 001232TA8 190073MR02 003439TA7 2626380 003441TA3 MRR10842 002687TA2 MRR10744 003440TA5 MRR10833 002090TA9 MRR10671 003793TA7 GON: 4393875 002949TA6 604988MRI 002219TA4 MRR10679 003212TA8 MRR10843 002876TA1 MRR10762 003177TA3 MRR10799 003754TA9 MRR10892 003359TA7 MRR5954 002885TA2 EG1826MR02 002450TA5 EG1990MR01 002886TA0 EG2266MR01 001502TA4 EG1112MR02 003213TA6 EG1709MR01 003083TA3 EG1522MR01 003133TA6 EG1237MR01 003354TA8 EG1505MR02 002446TA3 EG1196MR01 002940TA5 EG1998MR01 002743TA3 EG1245MR03 003267TA2 EG1069MR02 003172TA4 GP1022MR02 001405TA0 X227040904 001124TA7 A1039630 001231TA0 X2881410 000898TA7 M4174549 001307TA8 M23084330 003307TA6 M1265006 003511TA3 M1265008 001029TA8 X102860306 001171TA8 M185296206 001169TA2 X756087020 003265TA6 M2569125 000973TA8 M8321415 001028TA0 X116370509 001503TA2 M2269855 001233TA6 M2533228 001170TA0 M2748222 001936TA4 M2322255 001238TA5 M8317617 001938TA0 M215631205 000331TA9 M386271501 001123TA9 M2718163 001237TA7 X751964008 000965TA4 M203097404 002022TA2 M4213545 001251TA8 M2316318 001026TA4 RE1017MR01 002975TA1 X868131014 003725TA9 A1039633 003604TA6 M2485629 003783TA8 L2202007 003266TA4 GP1052MR03 003563TA4 M1974139 003730TA9 A6023417 003306TA8 X453783201 003600TA4 B1081916 003728TA3 X2266305 003566TA7 X1020807 003218TA5 RE1029MR01 003478TA5 RE1044MR02 003739TA0 396399MR02 002755TA7 HC0285MR01 001982TA8 PC1401MR01 000971TA2 387462MR01 003729TA1 PC7479MR04 001234TA4 527556MR02 003178TA1 410725MR01 003435TA5 HC1711MR01 001981TA0 570231MR02 003722TA6 487692MR01 000149TA5 "PC0345MR02 " 003475TA1 TP0009MR01 003301TA9 GON: 4389578 001411TA8 MRR1051 002218TA6 MRR3881 002739TA1 0828270047 001616TA2 0828270045 003507TA1 0828270050 003512TA1 828270049 001932TA3 HU1099MR02 003023TA9 HU1243MR02 002976TA9 083027848946716 002970TA2 083027607457016 003024TA7 083027108785616 003602TA0 083027108786816 001230TA2 083027000633815 001478TA7 083027210062849 002579TA1 083027245187515 003397TA7 083027247170216 003513TA9 083027241541616 002375TA4 083027242389615 002444TA8 083027243696615 003510TA5 083027240320216 001979TA4 083027062669515 003443TA9 083027000026516 003077TA5 083027828631016 001604TA8 083027861954815 003014TA8 083027867369616 001599TA0 083027869960115 001058TA7 083027280565115 001476TA1 083027282542615 002443TA0 083027201528815 002880TA3 083027207170016 003438TA9 083027200144616 001600TA6 083027209389215 003298TA7 083027209980616 003401TA7 083027600155416 001602TA2 083027601581615 002082TA6 083027064149415 002452TA1 083027045280015 002084TA2 083027803313615 001504TA0 083027803032115 003605TA3 083027801497116 002576TA7 083027804757116 003437TA1 083027809326316 002824TA1 083027847477816 003016TA3 083027848271716 003561TA8 083027840049116 002679TA9 083027845987715 001603TA0 083027021866615 003481TA9 083027024406116 002882TA9 083049026692016 000368TA1 083027607006215 003724TA2 083027609969016 002972TA8 5512MR0007 003504TA8 GON: 4410359 003480TA1 GON: 4409805 002677TA3 A5390311 001931TA5 A402682101 001407TA6 A339043902 000160TA2 C208415204 001771TA5 A5194602 003173TA2 AE1557MR01 003782TA0 A5388205 003210TA2 A344729901 003667TA3 A456623203 002683TA1 A5697716 003778TA8 A5820152 003214TA4 B5738501 001235TA1 A389746501 003215TA1 A5978807 002942TA1 MRR10827 002971TA0 PC0815 003217TA7 YM1450 002024TA8 PC0013 001479TA5 PC1007 002270TA7 PC0904 002382TA0 YM3057 001710TA3 PC1012 003080TA9 PC0813 000159TA4 "PC0801 " 001408TA4 PC1010 001937TA2 PC1013 002091TA7 PC1015 002085TA9 PC6050 002384TA6 PC0804 003514TA7 PC1026 001636TA0 PC1008 002826TA6 PC0814 003303TA5 PC1027 002083TA4 PC0803 002756TA5 PC1018 002878TA7 PC1023 003017TA1 PC0816 001475TA3 PC0802 001635TA2 PC0805 002622TA9 PC0809 002676TA5 PC1017 002685TA6 PC1022 003209TA4 PC0909 001406TA8 PC1004 002376TA2 YM0834 001253TA4 PC1002 002877TA9 PC0812 003355TA5 YM1462 001477TA9 PC0902 002829TA0 YM1745 002828TA2 PC1019 002086TA7 YM0534 002654TA2 YM4111 001934TA9 PC1009 002738TA3 PC1021 002943TA9 PC0006 000969TA6 PC1001 001499TA3 PC1011 001500TA8 YM0847 002442TA2 PC0807 003179TA9 PC1025 000970TA4 PC0901 003562TA6 PC1028 003483TA5 PC1100 001412TA6 PC0808 003219TA3 YM1705 001104TA9 PC1003 003398TA5 PC0912 003473TA6 PC0913 002379TA6 PC0806 002827TA4 PC0811 002884TA5 PC1020 002968TA6 PC1024 001252TA6 PC0888 002678TA1 YM0668 002445TA5 PC1014 001236TA9 PC1005 002026TA3 PC0810 002945TA4 PC0908 002675TA7 YM0659 003018TA9 YM0662 002476TA0 PC0906 002596TA5 PC0907 002944TA7 PC0911 003085TA8 PC0910 001250TA0 PC1006 002623TA7 PC1016 000966TA2 PC0905 003723TA4 PC1036 003131TA0 PC1030 001935TA6 PC0903 002977TA7 0850270494 003601TA2 0850270476 002088TA3 0850270483 002087TA5 0850270474 002624TA5 0850270479 002969TA4 0850270493 003360TA5 0850270496 003264TA9 0850270495 003560TA0 0850270497 002830TA8 0850270208 001249TA2 0850270472 002441TA4 0850270485 003779TA6 0850270141 001598TA2 0850270480 001498TA5 0850270473 001933TA1 0850270484 003304TA3 KW1013MR02 003299TA5 LB1005MR01 003361TA3 LB1220MR01 001254TA2 LT4028MR01 003506TA3 LT4022MR02 001501TA6 083027001828115 001229TA4 MQ1038MR03 002754TA0 This order is cancelled 001708TA7 MA1465MR01 001497TA7 MA1581MR01 001410TA0 MA1574MR01 002328TA3 MA1148MR01 002948TA8 MA1527MR01 003396TA9 MA1516MR01 003436TA3 MA1540MR01 003780TA4 GON: 4374894 002832TA4 RTD0123 003081TA7 85147575570 002973TA6 OM1087MR01 003082TA5 OM1121MR01 003211TA0 PK1248MR01 001775TA6 PK1242MR01 003358TA9 GON: 4395723 003784TA6 0843270007 000972TA0 PL3500MR01 002025TA5 PL3544MR02 001409TA2 PL3548MR01 002680TA7 PL3623MR01 002740TA9 PL3696MR01 001308TA6 PL3547MR01 002825TA8 PL3594MR01 001601TA4 PL1063MR01 000366TA5 "PL3362MR01 " 002757TA3 PL3697MR01 002267TA3 PL1724MR01 003795TA2 PL3810MR01 002268TA1 PL3595MR01 002684TA9 PL1778MR01 002595TA7 PL3596MR01 003075TA9 PPR58104 001496TA9 MRR1448 002875TA3 MRR3155 003084TA1 MRR2728 003479TA3 GON: 4420297 002447TA1 RO1321MR01 002381TA2 RO1311MR01 003400TA9 RO1090MR02 003022TA1 RO1200MR01 003020TA5 RO1252MR01 003402TA5 GON: 4381507 003021TA3 RO1038MR01 002221TA0 SA2330MR01 002089TA1 SA2468MR01 002383TA8 SA2167MR01 003753TA1 GON: 4398438 003305TA0 SA2118MR01 001980TA2 6073MR0008 002681TA5 1573MR0004 002220TA2 6073MR0009 002682TA3 0847270018 003505TA5 6073MR0012 002271TA5 ZA2222MR02 002440TA6 YP170A26 001770TA7 CP749713 002266TA5 FPG40900 002377TA0 FPG97802 003777TA0 DPN29025 003726TA7 GON: 4424831 002451TA3 YP602101 002378TA8 DEL71943 003132TA8 NPV71300 003308TA4 GON: 4399370 003353TA0 GON: 4399371 002575TA9 N006MR01 002881TA1 A013MR02 003357TA1 TZ1052MR01 003509TA7 1573MR0008 003603TA8 1573MR0007 003482TA7 1573MR0009 002655TA9 1573MR0003 002686TA4 1573MR0005 003433TA0 02008MRS01 001141TA1 06167MRS01 002449TA7 06169MRS01 003434TA8 16003MRS01 003442TA1 25008MRS01 002439TA8 34416MRS01 002021TA4 46008MRS01 003015TA5 06172MRS01 003622TA8 33044MRS02 003781TA2 GON: 4410001 002947TA0 34419MRS01 003477TA7 34433MRS01 003474TA4 52013MRS01 002946TA2 53012MRS01 003794TA5 09018MRS01 003130TA2 GON: 4294813 001769TA9 IE1590MR01 001404TA3 10718MRS01 001140TA3 10719MRS01 002941TA3 70001MRM01 002269TA9 10724MRS01 003300TA1 10079MRM83 003216TA9 5973MR0009 003476TA9 5973MR0010 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
Manufacturer Reason
for Recall
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
FDA Determined
Cause 2
Software design
Action Consignees were sent on 8/31/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 67921 dated August 31, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 383 (US = 24;OUS = 359)
Distribution US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, 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 HEALTHCARE (GE MEDICAL SYSTEMS,LLC)