Reported Sep 23, 2026 · Ongoing

Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions

GE Healthcare

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 · 500 W Monroe St · Chicago, IL · 60661-3671

Is this the product you have?

  • Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Lot codes and dates
  • UDI-DIV4 - 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

    84 of 84 codes

    • 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
    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

    104 of 104 codes

    • 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
    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

    90 of 90 codes

    • 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
    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
Amount recalled
1298 systems

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

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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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 2:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.