Class 2 Device Recall Workflow Core Services

• Date Initiated by Firm: July 31, 2026
• Date Posted: September 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3170-2026
• Recall Event ID: 99661
• 510(K)Number: K043415 K110875
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
• Code Information: System IDs: SevierCou21180109 PMIO26874968 VCM27268845 QTHBL25025522 GRHD20869086A GRHD20869566B GRHD20870043T VVMC22203148 LAKESIDEM22311789 OFMC22161726 OFMCProd24283369 AMCL20962675 LAKESIDEM21200035 NEUROSKEL22629460 FLMC24849713 FLMC23269955 MRMC220924399 MRMC221300628 MRMC221300631T 106684-1-Workflow Core Services-23253822 MRMC221306901 LaitekDataMigrationETPLab1WFC LaitekDataMigrationETPLab2WFC CMCM24346488 QTHDD22236119 QTHDD24934127 24489144TruePACSWFC 25248966TruePACSWFCT 22144965True_PACSWFC HANN21755240 HRHWFC HANN24283725 BC324463044 AMIM27024664 CHERRYCOU20906543 CHERRYCOU21180589T REDI21237465 MDHC26580426 VT25202652 NNAR21175649 104680-1-Workflow Core Services-24492064 NYK20996006 NYK21803243 NYK21803244 UNIVERSITY20575614 26325561TenantWFC NEWYORK26794149 26932125StgTenWFC 26403778TenantWFC RICHMONDU23210868 RICHMONDUWFCTest MFCI25178603 HZC20924408 HZC23291365 106633-1-Workflow Core Services-22208526 CCA20533413 CCA20609478 EVCH22176263 VBHC25014585 27109610TenantWFC 27112412StgTenWFC CMSImagingWFC HRMC21704042 Not Available 106520-1-Workflow Core Services-21291109 OPP25014573 DRISCOLLC26738355 MCHD120544438 MCHD20609496 URSA20991949 GZMG24480191 24819548TenantWFC EVG22631301 25199257TenantWFC Not Available Not Available Not Available Not Available Test TP PROD TP Not Available Not Available Test TP Prod TP Not Available Not Available 672721-Workflow Core Services-24280401 313741-Workflow Core Services-24280410 Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available Not Available 24488449 24488458 Not Available Not Available TBD Not Available tbd Not Available Not Available Not Available Not Available Not Available Not Available 106738-1-Workflow Core Services-24437872 HKBH21752373 534530-Workflow Core Services-23217329 SP_FORT_ETP_WFC RAPTAKOS_WFC_1 MMHRC-WFC RSUripSumoharjo_WFC PTAFFINITYHEALTH_WFC BETHSAIDA-ETP-WFC KeluargaGrandWisata-ETP-WFC RSUnpadJatinangor_WFC TestWFCKafeel01 Not Available Not Available 22138578 22138587 26991270 Not Available 24268633 Not Available 24336871 24336879 26978075 27079476 22225245 Not Available Not Available Not Available Not Available Not Available Not Available MOH-MY-WFC INTEGRATEDONCOLOGY-WFC Not Available Not Available ROP_TEMP002 MariaReyna-XavierUH-WFC StPaulHospital-WFC CMHCP27015653 Inobe23986382 PL3362-Workflow Core Services-22820442 SA1411_WFC SA1196_WFC 26368629 WFC_ETPACS_GON5361362 Not Available SrisawanBH-WFC 16861859 - WFC 16861859 - WFC2 ROH24368412P PRECISIONMEDICAL-WFC
• FEI Number: 3004526608
• Recalling Firm/ Manufacturer: GE Healthcare; 500 W Monroe St; Chicago IL 60661-3671
• For Additional Information Contact: GE 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: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 169 systems
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = LLZ; 510(K)s with Product Code = LLZ