Reported Sep 14, 2016 · Terminated
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
- Lot codes and dates
- Mfg Lot or Serial # System ID
MNEXP1600002MR480425MR7001709TA5520ASRMR003175TA7916RAFMR002448TA9559449SPMR002674TA0559449SPMR002027TA1203337MREXP003012TA2
- GON7
4371049002974TA4239458MR1003399TA3239292MR1002380TA4305983MR3002753TA2727869MR003356TA3954473MR1003176TA5773843SCMR000753TA4574206MR003013TA0508746JMR2003019TA7417269MRS2003371TA2601853MR1001027TA2704384MINT001059TA5
04384MINT002453TA9513569MR1002741TA7513584MR001063TA7254965CTOMR1002879TA5920560EXP002831TA6
- GON1532602 002023TA0 DZ1035MR03 002081TA8
- DZ1863MR01 003302TA7 GON4399202 002742TA5
- GON
4374136003076TA7DZ1149MR02003731TA7DZ2014MR01003079TA1DZ1908MR01003078TA3
- DZ1174MR01 003565TA9 GON
4345190003134TA4DZ1947MR01002883TA783147183761003174TA083140192745003508TA983151589682003403TA3083027600486516001232TA8190073MR02003439TA72626380003441TA3MRR10842002687TA2MRR10744003440TA5MRR10833002090TA9
- MRR10671 003793TA7 GON"PC0345MR02 " 003475TA1
140 of 140 codes
4393875002949TA6604988MRI002219TA4MRR10679003212TA8MRR10843002876TA1MRR10762003177TA3MRR10799003754TA9MRR10892003359TA7MRR5954002885TA2EG1826MR02002450TA5EG1990MR01002886TA0EG2266MR01001502TA4EG1112MR02003213TA6EG1709MR01003083TA3EG1522MR01003133TA6EG1237MR01003354TA8EG1505MR02002446TA3EG1196MR01002940TA5EG1998MR01002743TA3EG1245MR03003267TA2EG1069MR02003172TA4GP1022MR02001405TA0X227040904001124TA7A1039630001231TA0X2881410000898TA7M4174549001307TA8M23084330003307TA6M1265006003511TA3M1265008001029TA8X102860306001171TA8M185296206001169TA2
- TP0009MR01 003301TA9 GON
106 of 106 codes
4389578001411TA8MRR1051002218TA6MRR3881002739TA10828270047001616TA20828270045003507TA10828270050003512TA1828270049001932TA3HU1099MR02003023TA9HU1243MR02002976TA9083027848946716002970TA2083027607457016003024TA7083027108785616003602TA0083027108786816001230TA2083027000633815001478TA7083027210062849002579TA1083027245187515003397TA7083027247170216003513TA9083027241541616002375TA4083027242389615002444TA8083027243696615003510TA5083027240320216001979TA4083027062669515003443TA9083027000026516003077TA5083027828631016001604TA8083027861954815003014TA8083027867369616001599TA0083027869960115001058TA7083027280565115001476TA1083027282542615002443TA0083027201528815002880TA3
- GON4410359 003480TA1
- GON"PC0801 "
4409805002677TA3A5390311001931TA5A402682101001407TA6A339043902000160TA2C208415204001771TA5A5194602003173TA2AE1557MR01003782TA0A5388205003210TA2A344729901003667TA3A456623203002683TA1A5697716003778TA8A5820152003214TA4B5738501001235TA1A389746501003215TA1A5978807002942TA1MRR10827002971TA0PC0815003217TA7YM1450002024TA8PC0013001479TA5PC1007002270TA7PC0904002382TA0YM3057001710TA3PC1012003080TA9PC0813000159TA4
This order is cancelled181 of 181 codes
001408TA4PC1010001937TA2PC1013002091TA7PC1015002085TA9PC6050002384TA6PC0804003514TA7PC1026001636TA0PC1008002826TA6PC0814003303TA5PC1027002083TA4PC0803002756TA5PC1018002878TA7PC1023003017TA1PC0816001475TA3PC0802001635TA2PC0805002622TA9PC0809002676TA5PC1017002685TA6PC1022003209TA4PC0909001406TA8PC1004002376TA2YM0834001253TA4PC1002002877TA9PC0812003355TA5YM1462001477TA9PC0902002829TA0YM1745002828TA2PC1019002086TA7YM0534002654TA2YM4111001934TA9PC1009
001708TA7MA1465MR01001497TA7MA1581MR01001410TA0MA1574MR01002328TA3MA1148MR01002948TA8MA1527MR01003396TA9MA1516MR01003436TA3
- MA1540MR01 003780TA4 GON
4374894002832TA4RTD0123003081TA785147575570002973TA6OM1087MR01003082TA5OM1121MR01003211TA0PK1248MR01001775TA6
- PK1242MR01 003358TA9 GON"PL3362MR01 "
4395723003784TA60843270007000972TA0PL3500MR01002025TA5PL3544MR02001409TA2PL3548MR01002680TA7PL3623MR01002740TA9PL3696MR01001308TA6PL3547MR01002825TA8PL3594MR01001601TA4PL1063MR01000366TA5
002757TA3PL3697MR01002267TA3PL1724MR01003795TA2PL3810MR01002268TA1PL3595MR01002684TA9PL1778MR01002595TA7PL3596MR01003075TA9PPR58104001496TA9MRR1448002875TA3
- MRR3155 003084TA1 MRR2728 003479TA3 GON
4420297002447TA1RO1321MR01002381TA2RO1311MR01003400TA9RO1090MR02003022TA1RO1200MR01003020TA5
- RO1252MR01 003402TA5 GON
4381507003021TA3RO1038MR01002221TA0SA2330MR01002089TA1SA2468MR01002383TA8
- SA2167MR01 003753TA1 GON
4398438003305TA0SA2118MR01001980TA26073MR0008002681TA51573MR0004002220TA26073MR0009002682TA30847270018003505TA56073MR0012002271TA5ZA2222MR02002440TA6YP170A26001770TA7CP749713002266TA5FPG40900002377TA0FPG97802003777TA0
- DPN29025 003726TA7 GON4424831 002451TA3 YP602101 002378TA8 DEL71943 003132TA8
- NPV71300 003308TA4 GON4399370 003353TA0
- GON
4399371002575TA9N006MR01002881TA1A013MR02003357TA1TZ1052MR01003509TA71573MR0008003603TA81573MR0007003482TA71573MR0009002655TA91573MR0003002686TA41573MR0005003433TA002008MRS01001141TA106167MRS01002449TA706169MRS01003434TA816003MRS01003442TA125008MRS01002439TA834416MRS01002021TA446008MRS01003015TA506172MRS01003622TA833044MRS02003781TA2
- GON
4410001002947TA034419MRS01003477TA734433MRS01003474TA452013MRS01002946TA253012MRS01003794TA509018MRS01003130TA2
- GON
4294813001769TA9IE1590MR01001404TA310718MRS01001140TA310719MRS01002941TA370001MRM01002269TA910724MRS01003300TA110079MRM83003216TA95973MR0009003476TA95973MR0010
- Mfg Lot or Serial # System ID
- Amount recalled
- 383 (US = 24;OUS = 359)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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