| | Class 2 Device Recall SIGNA Artist and SIGNA Artist Evo |  |
| Date Initiated by Firm | August 27, 2026 |
|---|
| Date Posted | November 13, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0448-2027 |
|---|
| Recall Event ID |
99911 |
| 510(K)Number | K202238 K213603 |
|---|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product | SIGNA Artist
SIGNA Artist Evo |
|---|
| Code Information |
SIGMA Artist
Product - 1.5T SIGNA ARTIST EVO UPGRADE
Serial Number / System ID / UDI code:
IPGEV2400140SC 630833MRI (01)00195278117021(11)241000(21)IPGEV2400140SC
IPGEV2300012SC 937641MR (01)00195278117021(11)230300(21)IPGEV2300012SC
IPGEV2300013SC HPAD01MR01 (01)00195278117021(11)230300(21)IPEV2300013SC
IPGEV2400170SC MR00290 (01)00195278117021(11)241200(21)IPGEV2400170SC
Product - 1.5T SIGNA ARTIST FLO IPM
Serial Number / System ID / UDI code:
IPGAR2500009SC 13829180 (01)00195278117021(11)250300(21)IPGAR2500009SC
IPGEV2400101SC 019022MR01 (01)00195278117021(11)240700(21)IPGEV2400101SC
IPGEV2400098SC 019022MR07 (01)00195278117021(11)240700(21)IPGEV2400098SC
PGRART2500008 0853270243 (01)00195278117021(11)250801(21)PGRART2500008
IPGEV2400174SC 13051973 (01)00195278117021(11)250100(21)IPGEV2400174SC
PGRART2500014 205801TKCMR1 (01)00195278117021(11)250821(21)PGRART2500014
IPGAR2500017SC 208932MR1 (01)00195278117021(11)250500(21)IPGAR2500017SC
IPGAR2500003SC 216476MR (01)00195278117021(11)250200(21)IPGAR2500003SC
IPGAR2500026SC 314RAYUSMR (01)00195278117021(11)250611(21)IPGAR2500026SC
IPGAR2500027SC 336527MR1 (01)00195278117021(11)250627(21)IPGAR2500027SC
PGRART2500024 352333ERMRI (01)00195278117021(11)250908(21)PGRART2500024
IPGEV2400155SC 352401MR2 (01)00195278117021(11)241100(21)IPGEV2400155SC
IPGEV2400159SC 405949IBMR2 (01)00195278117021(11)241200(21)IPGEV2400159SC
PGRART2500011 423VAMRI (01)00195278117021(11)250806(21)PGRART2500011
PGRART2500002 480323SMCMR2 (01)00195278117021(11)250630(21)PGRART2500002
IPGEV2400164SC 502875ARTIST (01)00195278117021(11)241200(21)IPGEV2400164SC
PGRART2500005 509765ART (01)00195278117021(11)250701(21)PGRART2500005
IPGAR2500012SC 516231MR (01)00195278117021(11)250400(21)IPGAR2500012SC
PGRART2500054 539355MR1 (01)00195278117021(11)251119(21)PGRART2500054
IPGAR2500022SC 580223AMR2 (01)00195278117021(11)250528(21)IPGAR2500022SC
PGRART2500009 605504MRART (01)00195278117021(11)250801(21)PGRART2500009
IPGAR2500008SC 606408MRW (01)00195278117021(11)250300(21)IPGAR2500008SC
IPGEV2400119SC 608EMCMR3 (01)00195278117021(11)240800(21)IPGEV2400119SC
IPGAR2500001SC 614DRMCMR (01)00195278117021(11)250200(21)IPGAR2500001SC
IPGAR2500023SC 701775GEMR1 (01)00195278117021(11)250528(21)IPGAR2500023SC
IPGAR2500021SC 703504MR1 (01)00195278117021(11)250500(21)IPGAR2500021SC
IPGEV2400160SC 713572MR1 (01)00195278117021(11)241200(21)IPGEV2400160SC
IPGAR2500193SC 717738MR (01)00195278117021(11)250200(21)IPGAR2500193SC
IPGAR2500025SC 718780MR1 (01)00195278117021(11)250609(21)IPGAR2500025SC
IPGAR2500019SC 770400MR (01)00195278117021(11)250500(21)IPGAR2500019SC
IPGEV2400172SC 773270MR (01)00195278117021(11)250100(21)IPGEV2400172SC
IPGAR2500002SC 80428915T (01)00195278117021(11)250200(21)IPGAR2500002SC
IPGAR2500016SC 813685MR3 (01)00195278117021(11)250500(21)IPGAR2500016SC
IPGEV2400135SC 813MCCMR1 (01)00195278117021(11)241000(21)IPGEV2400135SC
IPGAR2500004SC 815968MR2 (01)00195278117021(11)250200(21)IPGAR2500004SC
IPGAR2500011SC 832826MR6 (01)00195278117021(11)250300(21)IPGAR2500011SC
IPGAR2500010SC 832912MR2 (01)00195278117021(11)250300(21)IPGAR2500010SC
PGRART2500006 859MR000011 (01)00195278117021(11)250718(21)PGRART2500006
IPGEV2500179SC 860889MRART (01)00195278117021(11)250100(21)IPGEV2500179SC
IPGAR2500020SC 901287ART2 (01)00195278117021(11)250500(21)IPGAR2500020SC
IPGAR2500007SC 904627MR4 (01)00195278117021(11)250200(21)IPGAR2500007SC
IPGEV2400151SC 904639MR2 (01)00195278117021(11)241100(21)IPGEV2400151SC
IPGEV2400115SC 913588WPMR (01)00195278117021(11)240900(21)IPGEV2400115SC
IPGEV2400167SC 913676LCCMR (01)00195278117021(11)241200(21)IPGEV2400167SC
IPGAR2500024SC 916784MR1 (01)00195278117021(11)250528(21)IPGAR2500024SC
PGRART2500019 916SUTARDENMR (01)00195278117021(11)250825(21)PGRART2500019
PGRART2500010 E416249MR1ART (01)00195278117021(11)250806(21)PGRART2500010
PGRART2500007 LVIPCMR (01)00195278117021(11)250718(21)PGRART2500007
IPGAR2500014SC LVITPMR (01)00195278117021(11)250400(21)IPGAR2500014SC
PGRART2500018 MCCLOLMR1 (01)00195278117021(11)250825(21)PGRART2500018
IPGEV2400171SC MR00291 (01)00195278117021(11)250100(21)IPGEV2400171SC
IPGEV2400152SC MR00296 (01)00195278117021(11)241100(21)IPGEV2400152SC
PGRART2500017 MR00316 (01)00195278117021(11)250825(21)PGRART2500017
IPGAR2500028SC MR1045981 (01)00195278117021(11)250627(21)IPGAR2500028SC
IPGEV2500180SC MR54443751 (01)00195278117021(11)250100(21)IPGEV2500180SC
IPGEV2400145SC MRPM1634 (01)00195278117021(11)241000(21)IPGEV2400145SC
PGRART2500003 MRPM1958 (01)00195278117021(11)250701(21)PGRART2500003
PGRART2500012 MRPM1991 (01)00195278117021(11)250812(21)PGRART2500012
IPGAR2500006SC NYPTO15TMR1 (01)00195278117021(11)250200(21)IPGAR2500006SC
IPGAR2500013SC SHMBLMR (01)00195278117021(11)250400(21)IPGAR2500013SC
PGRART2500016 VNMRI26563342 (01)00195278117021(11)250825(21)PGRART2500016
Product - 1-5T SIGNA ARTIST FLO IPM
Serial Number / System ID / UDI code:
IPGEV2400139SC Not Available (01)00195278117021(11)241000(21)IPGEV2400139SC
IPGEV2400104SC MRPM1500 (01)00195278117021(11)240700(21)IPGEV2400104SC
IPGEV2400109SC MRPM1458 (01)00195278117021(11)240700(21)IPGEV2400109SC
IPGEV2400118SC MR5678PE (01)00195278117021(11)240800(21)IPGEV2400118SC
PGRART2500013 0853270247 (01)00195278117021(11)250820(21)PGRART2500013
IPGEV2400163SC 0853270236 (01)00195278117021(11)241200(21)IPGEV2400163SC
Product - 3.0T SIGNA PIONEER MR28 FLO
Serial Number / System ID / UDI code:
IPGAR2500018SC 508998MR (01)00195278117021(11)250500(21)IPGAR2500018SC
Product - SIGNA Artist MDR IPGR with XG5, CTO
Serial Number / System ID / UDI code:
PGRART2500001 Not Available (01)00195278117021(11)250630(21)PGRART2500001
PGRART2500004 Not Available (01)00195278117021(11)250701(21)PGRART2500004
Product - UPG 1.5T LX UPGRADE
Serial Number / System ID / UDI code:
IPGAR2500015SC 209521SGMR2 (01)00195278117021(11)250400(21)IPGAR2500015SC
SIGNA Artist Evo
Product - 1.5T HDXT TO HD23 UPGRADE
Serial Number / System ID / UDI code:
IPGEV2400062SC 506452MR (01)00195278481382(11)240200(21)IPGEV2400062SC
Product - 1.5T SIGNA ARTIST EVO CPO
Serial Number / System ID / UDI code:
IPGEV2500206SC 501552SVNMR (01)00195278481382(11)250400(21)IPGEV2500206SC
IPGEVO2500011 203797MRCPO (01)00195278481382(11)250813(21)IPGEVO2500011
IPGEV2500212SC 402609EVO (01)00195278481382(11)250500(21)IPGEV2500212SC
IPGEV2500196SC 402AMIMR15 (01)00195278481382(11)250200(21)IPGEV2500196SC
IPGEV2500176SC 214420RDMR2 (01)00195278481382(11)250100(21)IPGEV2500176SC
IPGEV2400082SC 262544MR2 (01)00195278481382(11)240500(21)IPGEV2400082SC
Product - 1.5T SIGNA ARTIST EVO UPGRADE
Serial Number / System ID / UDI code:
IPGEV2400056SC 907796JMR (01)00195278481382(11)240100(21)IPGEV2400056SC
IPGEV2400092SC 256ALOPMR (01)00195278481382(11)240600(21)IPGEV2400092SC
IPGEV2400089SC 205934CVMR (01)00195278481382(11)240600(21)IPGEV2400089SC
IPGEV2400169SC 256543MR (01)00195278481382(11)241200(21)IPGEV2400169SC
IPGEV2500197SC 520381MR1 (01)00195278481382(11)250200(21)IPGEV2500197SC
IPGEV2500189SC 623478MR1 (01)00195278481382(11)250200(21)IPGEV2500189SC
IPGEV2200007SC 602406MR5 (01)00195278481382(11)221100(21)IPGEV2200007SC
IPGEV2400173SC 602512MR3 (01)00195278481382(11)250100(21)IPGEV2400173SC
IPGEVO2500006 916RASCMR (01)00195278481382(11)250718(21)IPGEVO2500006
IPGEV2500188SC 530894MR2 (01)00195278481382(11)250200(21)IPGEV2500188SC
IPGEV2500215SC 707428FFMR (01)00195278481382(11)250500(21)IPGEV2500215SC
IPGEV2400064SC UCDROCKMR (01)00195278481382(11)240200(21)IPGEV2400064SC
IPGEV2400148SC 719587MR (01)00195278481382(11)241100(21)IPGEV2400148SC
IPGEV2500185SC 303695MR (01)00195278481382(11)250100(21)IPGEV2500185SC
IPGEV2400085SC 303938MR (01)00195278481382(11)240500(21)IPGEV2400085SC
IPGEV2300010SC 970244AMPMR (01)00195278481382(11)230100(21)IPGEV2300010SC
IPGEV2400141SC 970248MR (01)00195278481382(11)241000(21)IPGEV2400141SC
IPGEV2300051SC 970RMOMR (01)00195278481382(11)231200(21)IPGEV2300051SC
IPGEV2400121SC 203453MR1 (01)00195278481382(11)240900(21)IPGEV2400121SC
IPGEV2400137SC 203407MREVO (01)00195278481382(11)241000(21)IPGEV2400137SC
IPGEV2300020SC 860231MR (01)00195278481382(11)230600(21)IPGEV2300020SC
IPGEV2400086SC 302744MR (01)00195278481382(11)240500(21)IPGEV2400086SC
IPGEV2400088SC RADNETMR1725 (01)00195278481382(11)240600(21)IPGEV2400088SC
IPGEV2400100SC 352333NFMR1 (01)00195278481382(11)240700(21)IPGEV2400100SC
IPGEV2500198SC 904399MR2 (01)00195278481382(11)250200(21)IPGEV2500198SC
IPGEV2400102SC 954978MR1 (01)00195278481382(11)240700(21)IPGEV2400102SC
IPGEV2400127SC 850678MR (01)00195278481382(11)240900(21)IPGEV2400127SC
IPGEV2300036SC 407303MRER (01)00195278481382(11)231000(21)IPGEV2300036SC
IPGEV2400161SC 727521MRI (01)00195278481382(11)241200(21)IPGEV2400161SC
IPGEV2500208SC 407CFRMR (01)00195278481382(11)250400(21)IPGEV2500208SC
IPGEV2400166SC 954724MR1 (01)00195278481382(11)241200(21)IPGEV2400166SC
IPGEV2500211SC 813751MR (01)00195278481382(11)250500(21)IPGEV2500211SC
IPGEV2300046SC 561650MR2 (01)00195278481382(11)231100(21)IPGEV2300046SC
IPGEV2300043SC 706651MR (01)00195278481382(11)231100(21)IPGEV2300043SC
IPGEV2400077SC 706481MR (01)00195278481382(11)240400(21)IPGEV2400077SC
IPGEV2500181SC 229276MR (01)00195278481382(11)250100(21)IPGEV2500181SC
IPGEV2400162SC 770644WHMR (01)00195278481382(11)241200(21)IPGEV2400162SC
IPGEV2300027SC 3012383 (01)00195278481382(11)230800(21)IPGEV2300027SC
IPGEV2400150SC 1323566 (01)00195278481382(11)241100(21)IPGEV2400150SC
IPGEV2500195SC 515247MR2 (01)00195278481382(11)250200(21)IPGEV2500195SC
IPGEV2300042SC 208529MR2 (01)00195278481382(11)231100(21)IPGEV2300042SC
IPGEV2400153SC 1000004646 (01)00195278481382(11)241100(21)IPGEV2400153SC
IPGEV2400147SC 630275MR3 (01)00195278481382(11)241100(21)IPGEV2400147SC
IPGEV2500225SC 1000004954 (01)00195278481382(11)250627(21)IPGEV2500225SC
IPGEVO2500013 1000004074 (01)00195278481382(11)250825(21)IPGEVO2500013
IPGEV2300030SC 812376MR1 (01)00195278481382(11)230800(21)IPGEV2300030SC
IPGEV2400065SC 574296MR (01)00195278481382(11)240200(21)IPGEV2400065SC
IPGEVO2500018 260266MR (01)00195278481382(11)250825(21)IPGEVO2500018
IPGEV2400072SC 812482MR1 (01)00195278481382(11)240200(21)IPGEV2400072SC
IPGEV2400059SC 913541OMR (01)00195278481382(11)240100(21)IPGEV2400059SC
IPGEV2400081SC 270793HDE (01)00195278481382(11)240400(21)IPGEV2400081SC
IPGEV2400112SC 502897BMR3 (01)00195278481382(11)240700(21)IPGEV2400112SC
IPGEV2500177SC 318214MR (01)00195278481382(11)250100(21)IPGEV2500177SC
IPGEV2500187SC 318675LMR2 (01)00195278481382(11)250200(21)IPGEV2500187SC
IPGEV2500219SC RADNETMR1510 (01)00195278481382(11)250600(21)IPGEV2500219SC
IPGEV2400124SC 410641MR1 (01)00195278481382(11)240900(21)IPGEV2400124SC
IPGEV2400120SC RADNETMR1546 (01)00195278481382(11)240900(21)IPGEV2400120SC
IPGEV2300016SC RADNETMR1548 (01)00195278481382(11)230500(21)IPGEV2300016SC
IPGEV2500182SC RADNETMR1507 (01)00195278481382(11)250100(21)IPGEV2500182SC
IPGEV2400128SC RADNETMR1505 (01)00195278481382(11)240900(21)IPGEV2400128SC
IPGEV2500205SC RADNETMR1578 (01)00195278481382(11)250300(21)IPGEV2500205SC
IPGEV2500200SC 734647MR (01)00195278481382(11)250200(21)IPGEV2500200SC
IPGEV2500203SC 989583MRI (01)00195278481382(11)250300(21)IPGEV2500203SC
IPGEV2400067SC 320693MR (01)00195278481382(11)240200(21)IPGEV2400067SC
IPGEV2400116SC 660259LMR (01)00195278481382(11)240800(21)IPGEV2400116SC
IPGEV2200004SC 406327AMR (01)00195278481382(11)221000(21)IPGEV2200004SC
IPGEV2400084SC 704384BALL (01)00195278481382(11)240500(21)IPGEV2400084SC
IPGEV2300018SC 402926NHI (01)00195278481382(11)230500(21)IPGEV2300018SC
IPGEV2300031SC 908828MR (01)00195278481382(11)230800(21)IPGEV2300031SC
IPGEV2300033SC 908890MR2 (01)00195278481382(11)230900(21)IPGEV2300033SC
IPGEV2300047SC 732745MR (01)00195278481382(11)231100(21)IPGEV2300047SC
IPGEV2400063SC 445MR2 (01)00195278481382(11)240200(21)IPGEV2400063SC
IPGEVO2500001 505437MR1 (01)00195278481382(11)250630(21)IPGEVO2500001
IPGEV2200002SC 505888MR (01)00195278481382(11)220600(21)IPGEV2200002SC
IPGEV2400142SC 775882MR (01)00195278481382(11)241000(21)IPGEV2400142SC
IPGEV2400068SC 702731MR3 (01)00195278481382(11)240200(21)IPGEV2400068SC
IPGEV2400057SC 914897MR (01)00195278481382(11)240100(21)IPGEV2400057SC
IPGEV2200005SC 718226MR2 (01)00195278481382(11)221000(21)IPGEV2200005SC
IPGEV2300034SC 330363MR (01)00195278481382(11)230900(21)IPGEV2300034SC
IPGEV2500190SC 614234MR (01)00195278481382(11)250200(21)IPGEV2500190SC
IPGEV2400144SC 937208MR3 (01)00195278481382(11)241000(21)IPGEV2400144SC
IPGEV2500223SC 330945MR (01)00195278481382(11)250600(21)IPGEV2500223SC
IPGEV2500184SC 614839MR (01)00195278481382(11)250100(21)IPGEV2500184SC
IPGEV2300022SC 330746MR (01)00195278481382(11)230700(21)IPGEV2300022SC
IPGEV2400093SC 740455MR (01)00195278481382(11)240600(21)IPGEV2400093SC
IPGEV2400075SC 580421VMR (01)00195278481382(11)240400(21)IPGEV2400075SC
IPGEV2500218SC 580931DMR (01)00195278481382(11)250600(21)IPGEV2500218SC
IPGEVO2500017 405604DMR (01)00195278481382(11)250825(21)IPGEVO2500017
IPGEV2200008SC 580774WMR (01)00195278481382(11)221200(21)IPGEV2200008SC
IPGEV2400130SC 541382SCMR (01)00195278481382(11)240900(21)IPGEV2400130SC
IPGEVO2500014 503399MR1 (01)00195278481382(11)250825(21)IPGEVO2500014
IPGEV2400149SC 610740MR1 (01)00195278481382(11)241100(21)IPGEV2400149SC
IPGEV2400080SC 610740MR2 (01)00195278481382(11)240400(21)IPGEV2400080SC
IPGEV2400136SC 412647MR3 (01)00195278481382(11)241000(21)IPGEV2400136SC
IPGEV2500199SC 412784MR2 (01)00195278481382(11)250200(21)IPGEV2500199SC
IPGEV2400117SC 610568MR (01)00195278481382(11)240800(21)IPGEV2400117SC
IPGEV2400113SC 215322MR2 (01)00195278481382(11)240800(21)IPGEV2400113SC
IPGEV2300039SC 864487UPMR (01)00195278481382(11)231000(21)IPGEV2300039SC
IPGEV2400126SC 843692MR (01)00195278481382(11)240900(21)IPGEV2400126SC
IPGEV2400156SC 423855PEMR (01)00195278481382(11)241200(21)IPGEV2400156SC
IPGEV2300035SC 615771MRMD (01)00195278481382(11)230900(21)IPGEV2300035SC
IPGEV2400131SC 901259MR (01)00195278481382(11)241000(21)IPGEV2400131SC
IPGEV2400073SC 615342MR3 (01)00195278481382(11)240200(21)IPGEV2400073SC
IPGEVO2500003 512TSISAMR (01)00195278481382(11)250701(21)IPGEVO2500003
IPGEV2400099SC 936539MR1 (01)00195278481382(11)240700(21)IPGEV2400099SC
IPGEV2400060SC 281758MR355 (01)00195278481382(11)240200(21)IPGEV2400060SC
IPGEV2300019SC 972560AICMR (01)00195278481382(11)230500(21)IPGEV2300019SC
IPGEV2500216SC 972566MR3 (01)00195278481382(11)250500(21)IPGEV2500216SC
IPGEV2400129SC 214220WBCMR2 (01)00195278481382(11)240900(21)IPGEV2400129SC
IPGEVO2500004 214559SRHMR1 (01)00195278481382(11)250701(21)IPGEVO2500004
IPGEV2400097SC 254897GRMR (01)00195278481382(11)240700(21)IPGEV2400097SC
IPGEV2300040SC 830426MCMR (01)00195278481382(11)231000(21)IPGEV2300040SC
IPGEV2200001SC 832522MR2 (01)00195278481382(11)220600(21)IPGEV2200001SC
IPGEV2300049SC 214420MR1 (01)00195278481382(11)231200(21)IPGEV2300049SC
IPGEV2400111SC 972434TSMR1 (01)00195278481382(11)240700(21)IPGEV2400111SC
IPGEV2400066SC 469815BCMR1 (01)00195278481382(11)240200(21)IPGEV2400066SC
IPGEV2300038SC 936568HDX (01)00195278481382(11)231000(21)IPGEV2300038SC
IPGEV2300028SC 972617REDMR1 (01)00195278481382(11)230800(21)IPGEV2300028SC
IPGEV2400158SC 210974NCBMR (01)00195278481382(11)241200(21)IPGEV2400158SC
IPGEV2300026SC 903533HDXT (01)00195278481382(11)230800(21)IPGEV2300026SC
IPGEV2300024SC 361572CICMR (01)00195278481382(11)230700(21)IPGEV2300024SC
IPGEV2300044SC 817599WRMR1 (01)00195278481382(11)231100(21)IPGEV2300044SC
IPGEV2200003SC 435HEBERMR1 (01)00195278481382(11)220700(21)IPGEV2200003SC
IPGEV2200009SC 801373MR4 (01)00195278481382(11)221200(21)IPGEV2200009SC
IPGEV2400091SC 801321LMR2 (01)00195278481382(11)240600(21)IPGEV2400091SC
IPGEV2400168SC 435789MR1 (01)00195278481382(11)241200(21)IPGEV2400168SC
IPGEV2500214SC 703893MR (01)00195278481382(11)250500(21)IPGEV2500214SC
IPGEV2400061SC 540SRMCMR (01)00195278481382(11)240200(21)IPGEV2400061SC
IPGEVO2500007 951276MR (01)00195278481382(11)250730(21)IPGEVO2500007
IPGEV2400071SC 804254LXMR (01)00195278481382(11)240200(21)IPGEV2400071SC
IPGEVO2500010 804675HDMR (01)00195278481382(11)250806(21)IPGEVO2500010
IPGEV2300041SC 540776MR (01)00195278481382(11)231000(21)IPGEV2300041SC
IPGEV2500224SC 802334MR360 (01)00195278481382(11)250600(21)IPGEV2500224SC
IPGEV2300050SC 425486EVMR (01)00195278481382(11)231200(21)IPGEV2300050SC
IPGEV2300023SC 509482MR2 (01)00195278481382(11)230700(21)IPGEV2300023SC
IPGEV2500213SC 509891MR (01)00195278481382(11)250500(21)IPGEV2500213SC
IPGEV2400123SC 253761CMMR (01)00195278481382(11)240900(21)IPGEV2400123SC
IPGEV2300032SC 920406HDX (01)00195278481382(11)230800(21)IPGEV2300032SC
IPGEV2400105SC 920720NSHD (01)00195278481382(11)240700(21)IPGEV2400105SC
IPGEVO2500005 715847MR1 (01)00195278481382(11)250718(21)IPGEVO2500005
IPGEV2500186SC 0910274036 (01)00195278481382(11)250100(21)IPGEV2500186SC
IPGEV2300021SC 833MR000035 (01)00195278481382(11)230600(21)IPGEV2300021SC
IPGEV2300014SC 833MR000032 (01)00195278481382(11)230300(21)IPGEV2300014SC
IPGEV2400143SC 2807634 (01)00195278481382(11)241000(21)IPGEV2400143SC
IPGEV2400157SC 44172 (01)00195278481382(11)241200(21)IPGEV2400157SC
IPGEV2500210SC 70537 (01)00195278481382(11)250400(21)IPGEV2500210SC
IPGEV2400132SC 250717MR (01)00195278481382(11)241000(21)IPGEV2400132SC
IPGEV2500222SC 613737MR2 (01)00195278481382(11)250600(21)IPGEV2500222SC
IPGEVO2500008 306766MR (01)00195278481382(11)250730(21)IPGEVO2500008
IPGEV2400083SC 450778MRI (01)00195278481382(11)240500(21)IPGEV2400083SC
IPGEV2400103SC Not Available (01)00195278481382(11)240700(21)IPGEV2400103SC
IPGEV2400090SC 514431MRI (01)00195278481382(11)240600(21)IPGEV2400090SC
IPGEV2400110SC 250370ARTIST (01)00195278481382(11)240700(21)IPGEV2400110SC
IPGEV2500201SC 250727MR1 (01)00195278481382(11)250300(21)IPGEV2500201SC
IPGEV2400108SC HVBMR01 (01)00195278481382(11)240700(21)IPGEV2400108SC
IPGEV2500226SC CS1065MR01 (01)00195278481382(11)250627(21)IPGEV2500226SC
IPGEVO2500002 Not Available (01)00195278481382(11)250701(21)IPGEVO2500002
IPGEV2400114SC DK1083MR06 (01)00195278481382(11)240800(21)IPGEV2400114SC
IPGEV2200006SC DK1001MR01 (01)00195278481382(11)221100(21)IPGEV2200006SC
IPGEV2300011SC DK1296MR01 (01)00195278481382(11)230300(21)IPGEV2300011SC
IPGEV2400074SC 0920279030 (01)00195278481382(11)240300(21)IPGEV2400074SC
IPGEV2500204SC HC0220MR02 (01)00195278481382(11)250300(21)IPGEV2500204SC
IPGEV2400107SC H5912MR02 (01)00195278481382(11)240700(21)IPGEV2400107SC
IPGEV2300029SC A5127236 (01)00195278481382(11)230800(21)IPGEV2300029SC
IPGEV2500220SC A5624132 (01)00195278481382(11)250612(21)IPGEV2500220SC
IPGEVO2500012 A5632405 (01)00195278481382(11)250820(21)IPGEVO2500012
IPGEV2500209SC A5632418 (01)00195278481382(11)250400(21)IPGEV2500209SC
IPGEV2400078SC MR00248 (01)00195278481382(11)240400(21)IPGEV2400078SC
IPGEV2500217SC MR00328 (01)00195278481382(11)250600(21)IPGEV2500217SC
IPGEV2300052SC MR00217 (01)00195278481382(11)231200(21)IPGEV2300052SC
IPGEV2500202SC MR00308 (01)00195278481382(11)250300(21)IPGEV2500202SC
IPGEV2400125SC MR00269 (01)00195278481382(11)240900(21)IPGEV2400125SC
IPGEV2300017SC MR00156 (01)00195278481382(11)230500(21)IPGEV2300017SC
IPGEV2400146SC MR00287 (01)00195278481382(11)241100(21)IPGEV2400146SC
IPGEV2500178SC MR00292 (01)00195278481382(11)250100(21)IPGEV2500178SC
IPGEV2400070SC MR00242 (01)00195278481382(11)240200(21)IPGEV2400070SC
IPGEV2300037SC MR00208 (01)00195278481382(11)231000(21)IPGEV2300037SC
IPGEV2400058SC MR00221 (01)00195278481382(11)240100(21)IPGEV2400058SC
IPGEV2400133SC MR00270 (01)00195278481382(11)241000(21)IPGEV2400133SC
IPGEV2400165SC MR00306 (01)00195278481382(11)241200(21)IPGEV2400165SC
IPGEV2400134SC MR00271 (01)00195278481382(11)241000(21)IPGEV2400134SC
IPGEV2400154SC MR00293 (01)00195278481382(11)241100(21)IPGEV2400154SC
IPGEV2300053SC MR00230 (01)00195278481382(11)231200(21)IPGEV2300053SC
IPGEV2400069SC MR00237 (01)00195278481382(11)240200(21)IPGEV2400069SC
IPGEV2400095SC MR00238 (01)00195278481382(11)240600(21)IPGEV2400095SC
IPGEV2400076SC MR00245 (01)00195278481382(11)240400(21)IPGEV2400076SC
IPGEVO2500048 525640SIGNA (01)00195278481382(11)251120(21)IPGEVO2500048
IPGEV2500192SC MR55222591 (01)00195278481382(11)250200(21)IPGEV2500192SC
IPGEV2300045SC FPG103200 (01)00195278481382(11)231100(21)IPGEV2300045SC
IPGEV2400055SC MPX82200 (01)00195278481382(11)240100(21)IPGEV2400055SC
IPGEV2400122SC UP506A13 (01)00195278481382(11)240900(21)IPGEV2400122SC
IPGEV2400138SC FPG25113 (01)00195278481382(11)241000(21)IPGEV2400138SC
IPGEV2500221SC DPB15820 (01)00195278481382(11)250600(21)IPGEV2500221SC
IPGEV2400087SC MEX68601 (01)00195278481382(11)240600(21)IPGEV2400087SC
IPGEV2300048SC FPG46909 (01)00195278481382(11)231200(21)IPGEV2300048SC
IPGEV2500183SC 70328MRS04 (01)00195278481382(11)250100(21)PGEV2500183SC
Product - 1.5T SIGNA ARTIST FLO IPM
Serial Number / System ID / UDI code:
IPGEV2400096SC 617754MR9 (01)00195278481382(11)240600(21)IPGEV2400096SC
Product - SIGNA Artist Evo IPGR with XG5, CTO
Serial Number / System ID / UDI code:
IPGEVO2600069 Not Available (01)00195278481382(11)260202(21)IPGEVO2600069
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| FEI Number |
3005326970
|
Recalling Firm/
Manufacturer |
GE Healthcare LLC
3001 W Radio Dr
Florence
SC
29501-7806
|
| For Additional Information Contact | Tracey Holevas
843-664-1488 |
|---|
Manufacturer Reason
for Recall | Due to an exposed sharp edge inside electronic cabinet that could damage power cables which could potentially pose an electrical fault such as an arc flash |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | On 08/27/2026, an "URGENT MEDICAL DEVICE CORRECTION" Letter was sent to customers informing them that, GE HealthCare has become aware of an exposed sharp edge inside the SIGNA Artist Evo and SIGNA Artist electronics cabinet that could damage power cables, which may potentially cause an electrical fault. If the electrical fault is present and the cabinet door is opened while the system is powered, this could potentially result in an arc flash that could lead to serious injury to service personnel in immediate proximity.
The issue would only present itself during servicing activities involving the electronics cabinet. The electronics cabinet is located within the equipment room and should only be accessed by qualified service personnel.
Actions to be taken by Customers:
Pending correction by GE HealthCare, you can continue to use the system. The electronics cabinet door should be closed any time there is power to the system. In the event the electronics cabinet needs to be serviced, your local GE HealthCare service representative or authorized third-party service providers are specifically trained and qualified to safely service your equipment, including the electronics cabinet, in accordance with standard GE HealthCare procedures and safety requirements detailed in the applicable GE HealthCare service manuals (Artist --- 5841150-2EN and Artist EVO --- 5884918-8EN).
Please retain this document for your records.
Please complete and return the attached acknowledgement form electronically via FMI 67959 Digital Response Form or print, fill out manually, scan, and email to recall.67959@gehealthcare.com.
GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction.
For questions - contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
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| Quantity in Commerce | 280 (200 US; 80 OUS) |
|---|
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and the countries of Austria, Belgium, Brazil, Canada, Chile, Costa Rica, Czech Republic, Denmark, Estonia, Fiji, Germany, Greece, Italy Japan, Mexico, New Zealand, Panama, Peru, Poland, Serbia, Spain, Taiwan, United Kingdom and Vietnam. |
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LNH
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