Workflow Core Services V8, intended to provide set of services for storage and retrieval of patie...
FDA Device Recall #Z-3170-2026 - Class II, July 31, 2026
Recall Summary
| Recall Number | Z-3170-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 31, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare |
| Location | Chicago, IL |
| Product Type | Devices |
| Quantity | 169 systems |
Product Description
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
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Lot / 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
Other Recalls from GE Healthcare
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3169-2026 | Class II | Centricity PACS Server V7, intended for managin... | Jul 31, 2026 |
| Z-3166-2026 | Class II | Centricity Enterprise Archive V2, V3, and V4, s... | Jul 31, 2026 |
| Z-3167-2026 | Class II | Enterprise Archive V8, software product for rec... | Jul 31, 2026 |
| Z-3168-2026 | Class II | Centricity PACS V2, V3, V4, V6, V7, software pr... | Jul 31, 2026 |
| Z-3171-2026 | Class II | Core Services Hub V8, a set of backend services... | Jul 31, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.