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RecallWatchMedical Device Safety
Class IIOngoingZ-3167-2026

GE Healthcare recalls Enterprise Archive V8

GE HealthcareChicago, IL, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
V4 - 00195278409287; System IDs: BIRMINGHAM20886386 SevierCou21180101 SevierCou21180111 UOAR24851211 UOAR23214501 CARTI27326017 KGM21766613T KGM21332085 KGM21677289 HRH323169307 HONORHEALT21179400 MIH…Show all
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 10290 …

What the firm is doing

An 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.

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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