FDA-Device2026-09-23Class IIPROCESSING DEFECT

GE Healthcare Core Services Hub V8 recalled for patient data misassociation risk

OTHERNationwide distributionMedical devicesBaby & kids

What this means

GE Healthcare's Core Services Hub V8 software, used by hospitals to manage medical imaging workflows, can sometimes link historical imaging data to the wrong patient record during system migrations. If this occurs, a doctor might view images belonging to a different patient, potentially leading to wrong diagnoses or delayed care.

  • If your healthcare facility uses Core Services Hub V8, contact GE Healthcare support to confirm whether your system is affected and for guidance on remediation steps.
  • Be alert to any imaging data that appears mismatched to a patient's medical record, and report it to your IT and clinical teams immediately.
  • Work with GE Healthcare on any software updates or corrective actions they provide.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
250 systems
Manufactured in
500 W Monroe St, N/A, Chicago, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3171-2026

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