Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Enterprise Archive V8

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Enterprise Archive V8see related information
Date Initiated by FirmJuly 31, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3167-2026
Recall Event ID 99661
510(K)NumberK110875 K043415 
Product Classification System, image processing, radiological - Product Code LLZ
ProductEnterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Code Information UDI-DI: V4 - 00195278409287; System IDs: BIRMINGHAM20886386 SevierCou21180101 SevierCou21180111 UOAR24851211 UOAR23214501 CARTI27326017 KGM21766613T KGM21332085 KGM21677289 HRH323169307 HONORHEALT21179400 MIHS25042933 MIHS25151161 MIHS25042933 MIHS25151165 MIHS25151166 ADHR27301883 PMIO26874972 PMHD27236488 PIPELINEH26974662 PIPELINEH27011598 SANFERNAN23238694 KRM22180898 MHL23269965 SUTH26668887 NORV21741298 24931893EdgeEA 25083358StgEdgeEA VCM27268846 SCRL24283967 SCRL23202147 SFGH24285530 USHC25292971 USHC26580362 GSH321314340 LosRobles23253832 QTHBL26325570 DENVERVA21733821 DENVER VA24406115 BOULDER22107026 BOULDER22107318 BOULDERCO24954910 HHL27121414 Not Available GRHD20869082A GRHD20869563B GRHD20870041T GRHD27231932 Not Available VVMC21290279 VVMC24397815 VVMC23203058 DDOC26923413 BAYHEALTH22212474 BAYHEALTH23201150 BAYHEALTHxxx BAYHEALTH26871762 JFKR20875123CEAGW 100029-1-Enterprise Archive-27124494 106428-3-Enterprise Archive-21313581 BYH24954908 BYH26856929 BYH26856932 LMC421600077 MH820838229 BIHT21020972 BIHT21305845 BIHT21305846 BIHT21305854 BIHT21305855 BIHT21305856 BIHT21310361 MH826770189 KRMC22464526 KRMC23157942 OFMC22161730T OFMC23066623P ORDC20944523 ORDC21315028 WELLINGTON27007867 RMCB23599904 PALMBEACH26587094 PALMBEACH26668888 AMCL21358642 CRMC21017209 HLEEMOFF21248284 HLEEMOFF21248387 HLEEMOFF21248397 BYH26649265 BYH26705437 BYH26782652 BYH26782654 WELLINGTON24453857 WELLINGTON24608353T LAKESIDEM21200034 LAKESIDEM21728988 WELLINGTON NEUROSKEL22629459 FLMC24438811EAT FLMC23269954EAP MRMC220924398 106590-2-Enterprise Archive-21847158 MRMC221300605 MRMC221300647T TRMCN25042932 106590-2-Enterprise Archive-25310918 MRMC226735314 MH826900860 SGHS21166828 SGHS21174955S SGHS24386768 106684-1-Enterprise Archive-23253823 ICA27062092 WHSS24437725 WHSS23208965 CWVM26790668 EID23167355 UIMC21180577EA1 UIMC21180577EA2 JHSJHOCC24505032 JHSJHOCC24509247 TUCM25188743 TUCM25191960 ULHH26814916 RPS27317305 LaitekDataMigrationETPLab1EA LaitekDataMigrationETPLab2EA SBLHC21734734 LUH22265885 LUH02040784-DRnew LUH02040782-NEW GSRHC21785099 NUHS22280599 NUHS21314339 NUHS22216248 MMC1026965751 CMCM24346487 CMCM24346492 CMCM24452475 CMCM24487883 QTHDD22236118 QTHDD24869161 GOSH26628096EAP GOSH26848461EAT RH&HCS27057456 RH&HCS27057460 RH&HCS27175494 RH&HCS27175495 RH&HCS27279853 RH&HCS27279854 UOKH24811226 UOKH24811229 UOKH21301549T WMC320902562 ROBERTJD22181590 ROBERTJD23269945 RRMC120533453 VTP24439530 VTP24439531 VTP24439532 VTP24439533 VTP24439534 VTP23206844 PENNINGTON26846052 LAKECHARL20915307 MCOLANO24481008 HTMC23248607 617754CAEASW BCH24276849 BCH24418535 CBSETINC22176271 SOPH21999192 UCHS22187612 FMH21847142 FMH21847143 FMH21984233 FMH21309178 FMH324335520 CMAE24827995T CMAE24827996 CMAE24827997 CMAE22910247 DMCHC26354533 MSUHEALTH26980320 SOPH21332082 SJHS126385949 24489147TruePACSEA 24849758TruePACSEAT PHSI26850720 CHILDRENS20900299T CHILDRENS21180532A CHILDRENS21180533B 22144964True_PACSEA OMCR21785104 OMCR22104771 OMCR22104772 OMCR21271177 OMCR26414480 24812812EdgeEA GOLDENVAL21367682T GOLDENVAL21367682 GOLDEN VAL21368374 HANN22108339 HANN21345752 SSMR24506653 MAGINGFO21243425 IMAGINGFO21254593 VT26705442 VT26716992 BC325168125 BC324463043 BC324829462 BC325239147 CTV20910640 CTV20910741 CTV21213416 CTV21214366 LNRMC22280606 LNRMC25230611 NCDC26959091 MINNETOHE26775597 AMIM24529400 AMIM26835357 Prod EA Prod EA DR PROD EA2 AMIM27024663 CHERRYCOU20906537 CHERRYCOU21180586T CHERRYCOU27220192 SOLUTIONHE24366756 SOLUTIONHE24397816 REDI21237464 VTH24848822 VTH24965840 VTH24965842 VTH24965915 VTH24965916 VTH24965917 VTH24965942 VTH24965944 VTH24965947 VTH24965955 VTH24965956 VTH24849759 VTH24965932 RFP20871012 RFP20919525 RFP20944473 RFP21767155 RFP21751111 RFP24286442 MDHC26580431 MDHC26602274 MDHC27268847 SHOREMEMO23212695 SHOREMEMO23238449 SHOREMEMO25249337 VT25202655 NNAR23300848 104680-1-Enterprise Archive-24494270 SH1120907273 VALLEYHEA20978654 VALLEYHEA20999368 VALLEYHEA21269957 VALLEYHEA21301552 VALLEYHEA20072493 VALLEYHEA20072644 VALLEYHEA20072493 VALLEYHEA20072494 107500-1-Enterprise Archive-27003896 NORTHERNN24533317 106407-1-Enterprise Archive-24815541 NORTHERNN23940931 STO23201188 NYK20996005 NYK21803239 NYK21803240 UNIVERSITY20575613 UNIVERSITY26715182 LISSP26659272 NSLI23248615 NSLI23248619 NSLI23248621 JAM21323960 MDHN01970427 SDMC20905771CEAP SDMC21696767 NSLI21200705 NSLI25222932 DRTTEST-21223105 NYP21248611 SKIRBALLC22311799 DRTEDLEA1-21368064 DRTEDLEA2-21368080 DRTEDLEA3-21223105 DRTEDLEA4-21223105 DRTEDLEA6-21368093 DRTEDLEAPRI-21368093 DRTEDLEA5-21223105 DELEDLEA1-21728965 DELEDLEA2-21728967 DELEDLEA3-21728973 DELEDLEA4-21728974 DELEDLEA5-21728975 DELEDLEA6-21728976 NEW YORK C24432412 BHC25168115 BHC25178554 BHC25178555 BHC225178556 BHC225178557T 26325565EdgeEA NEWYORK26794153 NEWYORK26832808 26893875StgEdgeETP Not Available VBH222181591 VBH23202148 SNCH23674758 RRA26403782 RRA26439240 STHS21207360 STHS21300112 STO26897892 RICHMONDU23210869 RUMCEATEST STO22174925 STO25151307 STO25629609 STO25629608 STO25629610 STO26775149 STO26775152 STO26775155 STO26918124 CRH24343148 SUPS24380470 SUPS23204387 CRH23302836 CRH23337987 SJHS125202657 NSLI24371967-DR-DB1 NSLI24371968-DR-DB2 NSLI24371969-DR-APP1 NSLI24371970-DR-APP2 NSLI24371971-DR-APP3 NSLI23204388 NSLI23296550-PROD-DB1 NSLI23296565-PROD-DB2 NSLI23296567-PROD-APP1 NSLI23296567-PROD-APP2 NSLI23296567-PROD-APP3 MRH21768675 MFCI21318105 MFCI23674759 OSU22187521Test MCHH21200103 MCHH21200104 MCHH21201491 OSU21291113 OSU21362822 OSU23253831 HZC20924409 HZC21242612 MEMORIALH22624423 MEMORIALH23253830 BH221360717 LMHV1EDLAPP121343634 LMH21269908EDLCldEdge LMH - LMHV1EDLAPP2 LMH-LMHV1EDLDB LMH-LMHV2EDLAPP LMH-LMHV2EDLDB 22308238-AIM 102901-2-Enterprise Archive-22308243 22308251EDLCldEAEdge 102901-2-Enterprise Archive-22308259 UTMC24375825 UTMC24449973 102901-2-Edge Enterprise Archive-24966113 TIET23251240EDLCldEA 102901-2-Genesis VNA?Edge Enterprise Archive Stage-27002757 102901-2-Genesis VNA?Edge Enterprise Archive-27002764 102901-2-Genesis VNA¿Edge Enterprise Archive-27054477 102901-2-Genesis VNA¿Edge Enterprise Archive Stage-27054478 102901-2-Genesis VNA¿Edge Enterprise Archive Stage-27175492 102901-2-Genesis VNA¿Edge Enterprise Archive-27175493 102901-2-Edge Enterprise Archive-27279850 102901-2-Genesis VNA¿Edge Enterprise Archive Stage-27279851 102901-2-Genesis VNA¿Edge Enterprise Archive-27279852 10240-2-Enterprise Archive-21301556 106633-1-Enterprise Archive-22464527 CCA20533412 CCA20609481 1499-1-Enterprise Archive-22111548 USOK21696764 OKOS22169797 OKOS23066622 USOK26635796 OSUM26747239 CCA27225759 ORTHOPEDIC20979873 QUANTUMIM21343631 WYMH22206967 STMARYME21362814 QUANTUMIM21734733 QUANTUMIM23214500 EVCH21358860 EHH21210951 13125-1-Edge Enterprise Archive-25014590 VBHC25230619 VBHC26353111 ErnestHea27109602 27112155StgEdgeEA STMARYME21364432 TJFH20901145 TJFH21296576 TJFH21311002 TJFH21311004 TJFH21311005 TJFH21311030 TJFH21311057 TJFH21311101 TJFH21311104 TJFH21311109 TJFH24453149 UHS120505974T UPMC21313582 UHS123215491 UPMC25022379 UPMC25022391 UPMC25022392 UPMC25022393 UPMC25022395 UPMC25022411 UPMC25022462 UPMC25022539 UPMC25022600 UPMC25022602 UPMC25022695 UPMC25022777 UPMC25022779 MNMC22174923-PROD-EA RDHMC24838433 RDHMC24838433 RDHMC24284488 CH622254200CARDEAP CH623210865CARDEAT AIMC22226450-TEA AIMC21368894-EA1 AIMC22139786-EA2 AIMC23206173 MUOSC24441136 MUOSC24530817 CH1126596218TPEAP LMC24346474 CMSImagingEA 106406-1-Enterprise Archive-23266499 CNOS26980315 HRMC21704044 HRMC21704043 Not Available WTN22108340 WTN21318131 COHE22311714 COHE24336909 BMHP26435456 HCA-COR-XR-VNA-STL-DCM-03-Q HCA-COR-XR-WIC-APP-PRI-6A-P HCA-COR-XR-WIC-APP-JPG-6B-P HCA-COR-XR-WIC-APP-JPG-6C-P HCA-COR-XR-VNA-STL-DCM-04-Q XRDC-P-WIC-DB-6B HCA-COR-XR-WIC-APP-PRI-6A-Q HCA-COR-XR-WIC-APP-JPG-6B-Q HCA-COR-XR-WIC-SQL-DBS-6A-Q _XRDC-Q-WIC-DB-6B HCA-COR-TP-VNA-APP-PRI-1C-P HCA-COR-XR-VNA-APP-DCM-2E-Q HCA-COR-XR-VNA-APP-PRI-2F-Q HCA-COR-XR-VNA-STL-DCM-03-P HCA-COR-XR-VNA-APP-HL7-1H-P HCA-COR-XR-VNA-APP-HL7-1G-P HCA-COR-XR-VNA-APP-HL7-1F-P HCA-COR-XR-VNA-APP-DCM-1E-P HCA-COR-XR-VNA-APP-DCM-1D-P HCA-COR-XR-VNA-APP-PRI-1C-P HCA-COR-XR-VNA-APP-DCM-1B-P HCA-COR-XR-VNA-APP-DCM-1A-P HCA-COR-TP-VNA-APP-DCM-1A-P HCA-COR-TP-VNA-APP-DCM-1B-P HCA-COR-TP-VNA-APP-DCM-1D-P HCA-COR-FW-VNA-APP-HL7-1H-P HCA-COR-TP-VNA-APP-DCM-1E-P HCA-COR-TP-VNA-APP-HL7-1F-P HCA-COR-TP-VNA-APP-HL7-1G-P HCA-COR-TP-VNA-APP-HL7-1H-P HCA-COR-TP-VNA-STL-STL-03-P HCA-COR-FW-VNA-APP-HL7-1G-P HCA-COR-FW-VNA-APP-HL7-1F-P HCA-COR-FW-VNA-APP-DCM-1E-P HCA-COR-FW-VNA-APP-DCM-1D-P HCA-COR-FW-VNA-APP-PRI-1C-P HCA-COR-FW-VNA-APP-DCM-1B-P HCA-COR-FW-VNA-APP-DCM-1A-P HCA-COR-FW-VNA-STL-DCM-03-P HCA-COR-XR-VNA-APP-PRI-2A-P HCA-COR-XR-VNA-APP-MNT-2B-P HCA-COR-XR-VNA-APP-MNT-2C-P HCA-COR-XR-VNA-APP-SRV-2D-P HCA-COR-XR-VNA-APP-SRV-2E-P HCA-COR-XR-VNA-APP-HL7-2F-P HCA-COR-XR-VNA-APP-HL7-2G-P HCA-COR-XR-VNA-APP-HL7-2H-P HCA-COR-XR-VNA-APP-MIG-2I-P HCA-COR-XR-VNA-APP-MIG-2J-P HCA-COR-XR-VNA-APP-MIG-2K-P HCA-COR-XR-VNA-APP-MIG-2L-P HCA-COR-XR-VNA-APP-DCM-2M-P HCA-COR-XR-VNA-APP-DCM-2N-P HCA-COR-XR-VNA-APP-DCM-2O-P HCA-COR-XR-VNA-APP-DCM-2P-P HCA-COR-XR-VNA-APP-DCM-2Q-P HCA-COR-XR-VNA-APP-DCM-2R-P HCA-COR-XR-VNA-APP-DCM-2S-P HCA-COR-XR-VNA-APP-DCM-2T-P HCA-COR-FW-VNA-APP-PRI-2A-P HCA-COR-FW-VNA-APP-MNT-2B-P HCA-COR-FW-VNA-APP-MNT-2C-P HCA-COR-TP-VNA-APP-PRI-2A-P HCA-COR-TP-VNA-APP-MNT-2B-P HCA-COR-TP-VNA-APP-MNT-2C-P HCA-COR-TP-VNA-APP-SRV-2D-P HCA-COR-TP-VNA-APP-SRV-2E-P HCA-COR-TP-VNA-APP-HL7-2F-P HCA-COR-TP-VNA-APP-HL7-2G-P HCA-COR-TP-VNA-APP-HL7-2H-P HCA-COR-TP-VNA-APP-MIG-2I-P HCA-COR-TP-VNA-APP-MIG-2J-P HCA-COR-TP-VNA-APP-MIG-2K-P HCA-COR-TP-VNA-APP-MIG-2L-P HCA-COR-TP-VNA-APP-DCM-2M-P HCA-COR-TP-VNA-APP-DCM-2N-P HCA-COR-TP-VNA-APP-DCM-2O-P HCA-COR-TP-VNA-APP-DCM-2P-P HCA-COR-TP-VNA-APP-DCM-2Q-P HCA-COR-TP-VNA-APP-DCM-2R-P HCA-COR-TP-VNA-APP-DCM-2S-P HCA-COR-TP-VNA-APP-DCM-2T-P HCA-COR-FW-VNA-APP-SRV-2D-P HCA-COR-FW-VNA-APP-MIG-2I-P HCA-COR-FW-VNA-APP-SRV-2E-P HCA-COR-FW-VNA-APP-HL7-2F-P HCA-COR-FW-VNA-APP-HL7-2G-P HCA-COR-FW-VNA-APP-HL7-2H-P HCA-COR-FW-VNA-APP-MIG-2J-P HCA-COR-FW-VNA-APP-MIG-2K-P HCA-COR-FW-VNA-APP-MIG-2L-P HCA-COR-FW-VNA-APP-DCM-2M-P HCA-COR-FW-VNA-APP-DCM-2N-P HCA-COR-FW-VNA-APP-DCM-2O-P HCA-COR-FW-VNA-APP-DCM-2P-P HCA-COR-FW-VNA-APP-DCM-2Q-P HCA-COR-FW-VNA-APP-DCM-2R-P HCA-COR-FW-VNA-APP-DCM-2S-P HCA-COR-FW-VNA-APP-DCM-2T-P HCAINFORM26545327 UHSD22715557 806354CCAT NORTHWEST23210863 UHSD23257118 4578-1-Enterprise Archive-25014572 STH22629464 DRISCOLLC26738359 DRISCOLLC26770213 DRISCOLLC26832811 DRISCOLLC26832818 DRISCOLLC26844103 DMCHC24816985 VVRM20910641 VVRMT MCHD120544437 MCHD20609498 MCHD127220220 FORTDUNCA22182079 FORTDUNCA21282127 MHHS20942592 MHHS20942701 MHHS20946684 MHHS20946685 MHHS20946687 MHHS20946688 MHHS20946689 MHHS20946690 MHHS20946692 MHSST20946693 MHSST20946694 MHSST20946695 MHSS20946696 MHHS22221194 MHHS22221195 MTT23237195 URSA21704056 STH22137993 STH22170041 STH24371989 STH24373447 GZMG24480190 WHBH23290085CEAP 24819552EdgeEA 24823900StgEdgeEA MFH223257269 DETARHOSP21737566 DETARHOSP24042533 DETARHOSP24042684 URHCS21350504 SMH827080177 10207-1-Enterprise Archive-21286821 EASTERNVI21771253 EASTERNVI21348888 RRMC21350503 RRMC-RRGEEA31 RRMC24436675 OVRLK24487937 OVRLK24487952 OVRLK24821681 OVRLK24821683 Prod EA 1 Prod EA 2 OVRLK27080130 EVG22173021 EVG24533001 EVG22631302 EVG23202137 EVG23208964 SRITEA0111292 MGH426556263 USA_MyImageCloud_EA CHH122298038-PROD-EAAPP testea 25199262EdgeEA CSPA27268843 HCIT4430774EA 83162039263 755757001 755757001 755757001 755757001 755757001 755757001 755757001 0910554032 0910554032 833IT000011 0910553037 AH4325-Enterprise Archive-24870870 Not Available Not Available Test TP PROD TP Not Available AH0116-Enterprise Archive-24870630 22016237 AH0106-Enterprise Archive-24870887 Prod TP PACSTPEA8 Not Available Not Available Not Available STJAN26710287 000 001 Not Available Not Available Not Available 337671-Enterprise Archive-22213152 HCIT5245250EA HCIT5245250EALTS HCIT5317135EALTS HCIT5317135EAGTW HCIT5559362EA HCIT5245275EA HCIT7104023EA8 HCIT5471924EA HCIT5529766EA HCIT5529151EA 416461EA80SW 519685EATMA 519685TESTEA 519685QAEA 519685EA 519685EAAPPA1 519685EAAPPA2 519685EAAPPA3 519685EAAPPA4 519685EAAPPA5 519685EAAPPA6 519685EAAPPA7 519685EAAPPA8 519685EAAPPA9 519685EAAPPA10 519685EAAPPA12 519685EATMB 519685QAEADB1 519685QAEAAPP1 519685QAEAAPP2 519685EADBA1 519685EADBA2 519685TESTEA80 519685EAAPPA11 519685EAAPPB11 519685EAAPPB12 519685EADBB1 519685EADBB2 519685EAAPPB1 519685EAAPPB2 519685EAAPPB3 519685EAAPPB4 519685EAAPPB5 519685EAAPPB6 519685EAAPPB7 519685EAAPPB8 519685EAAPPB9 519685EAAPPB10 519685EA80 519685QAEADB2 905943EA 905943EAAPPB01 905943EAAPPB02 905943EAAPPB03 905943EAAPPB04 905943EAAPPB05 905943EAAPPB06 905943EAAPPB07 905943EAAPPB08 905943EAAPPB09 905943EAAPPB10 905943EAAPPB11 905943EAAPPB12 905943EAAPPB13 905943EAAPPB14 905943QAEAAPP1 905943QAEAAPP2 905943TESTEA 905943TESTEADB 905943EAAPPA01 905943EAAPPA02 905943EAAPPA03 905943EAAPPA04 905943EAAPPA05 905943EAAPPA06 905943EAAPPA07 905943EAAPPA08 905943EAAPPA09 905943EAAPPA10 905943EAAPPA11 905943EAAPPA12 905943EAAPPA13 905943EAAPPA14 OCINET27011701 NEODIN27063451 SickKids27219146 705675EA-A HCIT5183890EA N/A Not Available RSJ24364044NTT RSJ24364044STT RSJ24364044NTP3 RSJ24364044STP RSJ24364044NTP1 RSJ24364044NTP2 HCIT5162696EA Hansa12345 Not Available A41676-Enterprise Archive-25311317 A41676-Enterprise Archive-25311324 M614219-Enterprise Archive-27017075 CHAR27017082 Not Available MQ12345 / MQ1090-Enterprise Archive-26561962 MQ12345 / MQ1090-Enterprise Archive-26561969 M3865783-Enterprise Archive-27017058 M3865783-Enterprise Archive-27017065 Not Available 24516664 27357588 22184090 C41917 Not Available 245401-Enterprise Archive-23986398 21287819 26682257 M2209952-Enterprise Archive-26876043 CHOG26876050 Not Available Not Available Not Available Not Available 24472129 24488448 24488457 Not Available Not Available 16921400-Enterprise Archive-25194304 Not Available Not Available EA26826319 Not Available GEEA1 GB24823070 Shadow EA GEEA2 GEEA3 Not Available Not Available TBC 22130880 Not Available Not Available Not Available tobecreated 600791-Enterprise Archive-24825127 UKHD23289129 UKHD23289129 Not Available HC4929EA24432746 Not Available PC1961PC02 Not Available Not Available uspearc2 22240981 Not Available Not Available Not Available NSK24490523 Not Available Not Available Not Available GEKBEA2025 106738-1-Enterprise Archive-24437871 HKBH21752369 N.A. 0828550109 JAWAHAR_EA GAYA-EA-001 PGI-EA-002 BILASPUR-EA-001 VENKAT_EA 9313623-Enterprise Archive-26801259 ARTEMIS-EA 534530-Enterprise Archive-23217325 IGMC-EA SP_FORT_EA UNITED-EA-001 RAPTAKOS_EA_8 JIPMER27289987 MMHRC-EA Not Available RIMS - EA KGMU-EA TMCV-MPMMCC-EA RSUDSOREANG-EA RSUDMadaniPalu-EA TEASIAHEALTHCARE-EA MayapadaBandung-EA RSKELUARGAKALIDERES-EA RSUPTVertikalKupang-EA RSBrawijayaTamanMini-EA SANTOSA-EA RSUDSlawi-EA RSReginaMaris-EA RSUDKlungkung-EA RSUripSumoharjo_EA PTAFFINITYHEALTH_EA MandayaAntasari-EA PTUNISIAMEDIKAFARMA_EA MitraKeluargaSlawi-EA RSMardiRahayu-EA Dr.MOHAMMADZYN_EA BETHSAIDA-ETP-EA MitraKeluargaPamulang-EA KeluargaGrandWisata-ETP-EA RSUDTelukKuantan-EA HoesinPALEMBANG-EA RSBinaHusadaCibinong-EA RSUnpadJatinangor_EA 17124473_EA8 EAKafeel01 527075EA01 IE1077-01 IE1077-02 21198481 IL1018IT20 24274948 IL1484IT24 IL1484IT01 IL1484IT05 IL1484IT06 IL1484IT07 IL1484IT08 IL1484IT09 IL1484IT10 IL1484IT11 IL1484IT12 IL1484IT13 IL1484IT02 IL1484IT23 IL1469IT02 Not Available 26633027 B5820898 21763957 22138582 22138591 22140045 A58070EA04GW 27450533 24448023 26640589 27003756 Not Available 20884830 TBD 710920-Enterprise Archive-25236131 16706819EA01 22106136 24268629 Not Available B53768-Enterprise Archive-26543861 B53768-Enterprise Archive-26543870 Not Available nxaqvnasas02 nxaqvnapas01 nxaqvnasas01 nxtlvnapas01 nxtlvnasas01 nxtlvnasas02 Not Available A56306-Enterprise Archive-25194086 24336869 26978036 26978038 27455910 27455911 Not Available 24434116 24439354 Not Available 26944081 26944080 26944743 26944744 22225249 ESREA01 ESREA02 703556-Enterprise Archive-27157316 553884-Enterprise Archive-25203491 Not Available TestEA Not Available 24838810 26666754 26667558 24305480 26982155 26982157 Not Available 17079118-Enterprise Archive-26914960 17079118-Enterprise Archive-26914969 24510361 27004455 27004456 27455929 Not Available PV2069 PV2077 PV2065 PV2075 PV2074 PV2067 PV2084 PV2073 PV2087 PV2088 PV2094 PV2092 PV2062 PV2096 PV2064 PV2099 PV2066 PV2080 PV2070 PV2045 PV2095 PV2078 PV2091 PV2081 PV2082 PV2068 PV2090 PV2072 PV2097 PV2048 PV2086 PV2079 PV2089 PV2093 PV2083 PV2098 PV2085 PV2063 085055031601 085055026865308 59219_ERPerror-Enterprise Archive-22631346 KW1003-EA8LTA 59219-Enterprise Archive-27198013 KW1011PC01 KW1018PC01-Temp KW1013_EA8 RAZIEA Not Available SEGAMATSH-EA HUSM-EA8 17191257-Enterprise Archive-26628541 REGENCY-EA8 UTAR-EA8 MOH-MY-EA HPUPM-EA INTEGRATEDONCOLOGY-EA DVT0164 Not Available 5457820EA to be created 22254810 GRN01EA01 GRN01EA02 HDREA02 LDNEA01 LUMC24827272T TBC TBC UMCU-EA-TEST UMCU-EA-PRDO Not Available ROP_TEMP008 Medequal-EA MariaReyna-XavierUH-EA StPaulHospital-EA PHC-EA CSMC-EA PL1731PC01 tempaffideaELK2EA InobTBD Not Available Not Available Not Available AFFIDEA24834130 AFFIDEA24843511 AFFIDEA24843048 CMHCP27015658 AFFIDEA24840131 AFFIDEA24839477 PL1631PC01 AFFIDEA24840119 25265098 Inobe23986378 PL3362-Enterprise Archive-22820445 Not Available Not Available PL1544PC01 AFFIDEA24840210 Not Available Not Available SA2706PP06 - EA8 TEST SA2706PP06 - EA8 Prod Not Available SA1234_EA Not Available SA2128_EA SA1411_EA EA8VNA Not Available SA1233_EA Not Available SA2939PP02 SA1234_EA KAMCJEA8 KFHEA MKKAHEA MKNSHEA EMC104_BC_EA Not Available SA1058_EA_WH_PROD SA1054_KFMC_EA SA1196_EA SA2110_EA_CARD_NEW EMC104_PROD_EA Not Available Not Available EMC104_TEST_EA Saudi_RMC_EA8 SA1017_EA8 SA1339_EA8 Not Available RAFFLES-EA NNI-SG-EA8-Test NNI-SG-EA8-Prod SG-KTPH-EA8 930879-Enterprise Archive-24821326 DEMO-EA8 WHC-EA NUHS-EA8 NUH-SG-EA8 TTSH-RAD-EA8 NUHSD-EA100-EA8 Not Available TTSH-CVIS-EA8 WHC-EA-TEST ZA1025_EA ZA1352-EA8 ZA1025_EA ZA00127EA01 ZA2895EA03 24963093 ME5043123 Not Available ME2443303 MPX43208 FEG51879 FEG51880 25262342 GPX46201 GPX45801 GPX45901 ME620549 MEX689490 MEX67316 MEX67317 MEX689491 IPRO-26353437 Not Available GEX18406 26368618 GEX00202 GEX00208 GPX02137 GEC21891 GED64907 GPX37900 GPX46700 GPX46800 DEN272199 DEL264130 DEL264137 DPN67209 DPN67210 DEN51504 DE492A106 25307259 GEQ20334 Not Available Not Available MANPB239 27450520 Not Available ME2566100 24846043 DE5392118 26652219 TBC ea1234 MED09307 FEF11238 GE448026 GPX23405 TBDTorrevieja NEV44000 NEV44039 NPV79384 Not Available NEV44040 NEV44041 NEV44042 NEV44043 NEV44044 NEV44045 NEV44046 NEV44047 25307292 Not Available 27327948-XDSEA1 TBD TBC Not Available GPQ13110 GPQ13111 UEW19901 GPX46500 GPX46600 GPX46101 GPX46001 DigPat-VGRBFR22243150T VGRBFR22243187DC1 VGRBFR22243196DC2 TBC EA_ETPACS_GON5361362 Not Available Not Available Not Available EA8 Not Available 529150RW02 CGMHCYI27121411 CYCH27310747 0853551141 YGH26357945 CGMHKEL26376480 0853551140 0853551139 Not Available CSH26950033 EMECCA27425676 0853551142 SrisawanBH-EA 16861859 - EA1 16861859 - EA2 Not Available 34412PAC_EA8Node1 34001PAC05 34394PAC01 Not Available 41400PACEA - CARD Not Available AE1564_EA8 60638EA003 60638EA004 Not Available Not Available 24482569 RFSDAVM058 Not Available NCAEA01 RWDDAVM058 DCEAAP21-26 QSIC-EA8 Not Available ROH24368411EAP ROH26651669 ROH26651678 Not Available 22111450 Not Available TBC TBC TBC RWEEA01 RWEEA02 RWEEA03 RWEEA04 DCKGHEA01 NUHEA20 PRDC0VM189 NorthumbriaSH24866766 Not Available RNS01VM052 EA01 Xeleris NCCAR-XEL-APP02 Not Available Not Available MidYorkshire24402306T Not Available EA Node 1 EA Node 2 Not Available Not Available Not Available 3878642-Enterprise Archive-27233089 VinmecOceanPark-EA VINMECSMARTCITY-EA K1Hospital-EA BenhVienGiaAn115-EA BVQY01 TanHungGeneralHospital-EA INH-EA CARESNOVA01 NguyenTraiHospital-EA PRECISIONMEDICAL-EA VinmecCanTho-EA NCH-Phase2-EA BenhVienDaKhoaKhuVucThuDuc-EA XuyenALongAn-EA8 XuyenATayNinh-EA8 XuyenAVinhLong-EA8
FEI Number 3004526608
Recalling Firm/
Manufacturer		 GE Healthcare
500 W Monroe St
Chicago IL 60661-3671
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your systems by following the instructions below. 1. Do not perform any new inbound data (DICOM) migration projects. Please contact GE HealthCare before starting any new migration projects. 2. If using Enterprise Archive with Core Services Hub/Workflow Core Services, when reviewing or exporting prior imaging studies after migration to Enterprise Archive, verify that the study and images within the study are associated with the correct patient as follows: At the Study level: " Compare name, date of birth, and patient identifiers only if burned-in or embedded in the image. Do not rely on patient information in the image overlays that can be toggled on and off. " If burned-in or embedded patient identifiers are not available, compare with prior studies based on patient anatomy, implants, or unique anatomical features. At the Image level: " Confirm that the images within the study do not belong to different patients based on acquisition date and time or other patient identifiers. Please maintain any previous source systems or migration servers pending correction of this issue by GE HealthCare. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions above. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 85492 Digital Response Form or print, fill out manually, scan, and email to recall.85492@gehealthcare.com. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce1298 systems
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
-
-