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U.S. Department of Health and Human Services

Class 2 Device Recall Core Services Hub

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 Class 2 Device Recall Core Services Hubsee related information
Date Initiated by FirmJuly 31, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3171-2026
Recall Event ID 99661
510(K)NumberK110875 K043415 
Product Classification System, image processing, radiological - Product Code LLZ
ProductCore Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
Code Information System IDs: CARTI27326018 KGM24849767P2 KGM26790380P1 KGM26790386T1 KGM26790388T2 PIPELINEH26974665 PIPELINEH27036913 KRM25208408 26885371TenantCSH 26897935StgTenCSH VVMC25199249 Not Available VVMC26130320 DDOC26923416 BAYHEALTH26580398 BAYHEALTH26871765 JFKR27127669 LAKESIDEM27124493 BYH25222926 LMC427127671 KRMC27127670 MH826900861 ICA27062095 NORTHWEST24866978-XE NORTHWEST27294841-XE NORTHWEST27294843-XE JHSJHOCC24849766 ANN & ROBE24866975 JHSJHOCC27005469 GOSH26799709CSHP GOSH26848483CSHT CMAE26304473 CMAE26774289 MSUHEALTH26980323 Not Available CHILDRENS24808132 XE VCP 103829-6-CoreServices Hub-XE VMP 103829-6-CoreServices Hub-XE Test 103829-6-CoreServices Hub-WFC VCP 103829-6-CoreServices Hub-WFC VMP 103829-6-CoreServices Hub-WFC Test OMCR25206023 ETP Prod CoreServices 1 ETP Prod CSH 2 CHILDRENS25171538 26885369TenantCSH BC325168126 BC324829461 BC325239077 BC325239084 BC326538517 NCDC26959094 MINNETOHE26945472 AMIM27062090 VTH26323581 SHOREMEMO24810482 SHOREMEMO24988230 SHOREMEMO25249340 VT27062091 NNAR25264207 107500-1-CoreServices Hub-27003899 UNIVERSITY26715185 MSI25263844 RRA24845093 RICHMONDU26628093 MFCI24810480 MFCI24825168 LMH25269182 TIET24966115 UTMC25263843 USOK26760295 CCA26850726 WYMH26492340 EVCH24849763 106483-1-Tenant CoreServices Hub-27124492 UHS125299932 ANMEDHEA25206013 ANMEDHEA26129703 CH1126596219TPCSHP CNOS26980316 OPP25269183 MHHS24845097 GZMG24848821 26885370TenantCSH 26898047StgTenCSH OVRLK25074987 Prod WFC 2 Prod WFC 1 EVG26454426 EVG26973916 MGH426804058 CSPA27063452 PACSTPSRV Not Available HCIT5559362DB HCIT5529151XEWFC HCIT5529766XEWFC 604520XES 604520XE1 604520TESTXE 604520ZFP--CSH 604520TESTZFP--CSH 604586XE2 HHS25206021 613548TESTUV--XES 613548UV2--XES 613548UV1--XES 905943ZFP--CSH 905943TESTZFP--CSH 905943QAZFP--CSH 705675ZFP-XES to be created to be created Not Available Not Available Not Available Not Available To be created Not Available Not Available HEIDELBERGXXX HEIDELBERGXES Not Available Not Available Not Available GEXESRV2025 RSBrawijayaTamanMini-CSH MandayaAntasari-CSH 17124473_CSH 21198484 26595807 26595810 26990976 26640586 26642289 26944877 Not Available Not Available 24434118 24434119 24439365 WFC 26861703 wfc 26861736 26861739 26861738 wfc wfc 26861906 26944007 26944686 26944742 26944700 26944741 Not Available TestCOREHUB 26640835 26641110 26968050 25302539 26982132 2698213 Not Available 24510364 27004491 27004492 TBC YP2214-CoreServices Hub-27071699 YP2205-CoreServices Hub-24934141 YP2217-CoreServices Hub-27439155 YP2213--CoreServices Hub-26918259 YP2211-CoreServices Hub-26606203 YP2209-CoreServices Hub-25303969 YP2207-CoreServices Hub-25194301 YP2208-CoreServices Hub-25012611 YP2210-CoreServices Hub-26671911 YP2216-CoreServices Hub-27225798 Not Available Not Available SEGAMATSH-CSH HUSM-CSH 17191257-CoreServices Hub-26628545 SgPetani-CSH MOH-MY-CSH HPUPM-CSH PHC-CSH Not Available Not Available Not Available Not Available Not Available SA2410_CSH_DMZ Not Available Not Available SA2385_CSH_DMZ SA2385_CSH_Prod KAMCJXE Not Available SA2329_CSH_DMZ SA1006_CSH_PROD SA1006_CSH_DMZ Not Available SA1176_CSH_DMZ KFHAD MKAHXE Not Available Not Available SA1025_CSH_DMZ EMC104_PROD_CSH Not Available C2_CSH_Central Saudi_RMC_CSH_PROD SA2110_CSH_PROD SA2110_CSH_TEST Saudi_RMC_CSH_TEST Not Available C2_CSH_RemoteSites Not Available Saudi_NEOM_AlJeel_CSH SA2393_CSH_PROD SA2393_CSH_DMZ SA1279_CSH Not Available SA1175_CSH_DMZ 26368579 Not Available 26629975 24467987 XEPRODCOM3 XEPRODCOM1 XEPRODCOM2 CGMHCYI27253990 Not Available 6935589 CSH26950034 Not Available SrisawanBH-CSHub testCrossEnterpriseService01 Not Available AE1564_CSH_CARD rohwfc01 update to system id CoreServices Hub Not Available Not Available VinmecOceanPark-CSH VINMECSMARTCITY-CSHub K1Hospital-CSH NguyenTraiHospital-CSH VinmecCanTho-CSH
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 Commerce250 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
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