GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical software) where the hazard is misdiagnosis or delayed care, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
GE Healthcare is recalling Centricity PACS software, versions 2, 3, 4, 6, and 7. This software is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
The recall is issued because, 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.
The recall affects 1,443 systems distributed worldwide and nationwide in the US. Healthcare facilities using this software should contact GE Healthcare for instructions on how to resolve the issue and ensure patient data integrity.
The recalled product
- Product
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
- Manufacturer
- GE Healthcare
- Affected units
- 1,443
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: V4 - 00840682124430
- V6 - 00840682104807
- V7 - 00840682145572
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · GE Healthcare
See all →- HighGE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
Same hazard · data integrity
See all →- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Foundation Software
FDA (Devices) · 2019-07-10
- HighGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- ModerateGE Centricity PACS Workstation Recalled for Image Grouping Errors
FDA (Devices) · 2016-08-24
- HighGE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGe Healthcare Recalls Imagecast PACS Software Due to Image Context Defect
FDA (Devices) · 2016-08-03