GE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
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 where misdiagnosis or delay in care is possible, 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 116 units of the Centricity PACS Server V7, a system intended for managing digital medical images and associated data. The recall covers all versions of the product and involves systems distributed worldwide and nationwide in the United States.
The recall was initiated 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.
Healthcare facilities and users of the affected systems should contact GE Healthcare for further instructions on how to address the data association issue.
The recalled product
- Product
- Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
- Manufacturer
- GE Healthcare
- Affected units
- 116
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 (1)
- UDI-DI: 00195278882585
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 Software Due to Data Association Errors
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 · misdiagnosis
See all →- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
- SevereNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
Similar recalls
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
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 Centricity PACS Foundation Software
FDA (Devices) · 2019-07-10
- HighGE Healthcare Recalls Workflow Core Services V8 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 Enterprise Archive V8 Software Recalled for Data Association Errors
FDA (Devices) · 2026-09-23