GE Healthcare Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, Centricity PACS Server, Workflow Core Services, and Core Services Hub Software
Centricity Enterprise Archive software may associate historical imaging data with the wrong patient, potentially causing misdiagnosis or delayed care.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
GE Healthcare, based in Chicago, Illinois, began a recall on July 31, 2026, for several software products, including Core Services Hub V8, Enterprise Archive V8, Centricity PACS V2, Workflow Core Services V8, Centricity PACS Server V7, and Centricity Enterprise Archive V2.
Under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient, causing studies or images to be displayed under the wrong patient record, which could lead to misdiagnosis or delayed patient care. The FDA added the recall to its Enforcement Report on September 15, 2026, with nationwide distribution.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
6 products
Affected if its UDI-DI is listed.
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
- UDI-DI
- 27003899
- 27124492
- Recall #
- Z-3171-2026
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
- UDI-DI
- 00195278409287
- 27124494
- 21313581
- 21847158
- 25310918
- 23253823
- Recall #
- Z-3167-2026
- UDI-DI
- 00840682124430
- 00840682104807
- 00840682145572
- 21222171
- Recall #
- Z-3168-2026
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
- UDI-DI
- 23253822
- 24492064
- 22208526
- 21291109
- 24280401
- 24280410
- 24488449
- 24488458
- 24437872
- 23217329
- Recall #
- Z-3170-2026
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
- UDI-DI
- 00195278882585
- 20034126
- 25277590
- Recall #
- Z-3169-2026
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
- UDI-DI
- 00840682102766
- 20940705
- 21771222
- Recall #
- Z-3166-2026
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Event ID
- 99661
- Recall numbers
- Z-3166-2026 to Z-3171-2026
- Company
- GE HealthcareChicago, Illinois
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
