GE Healthcare Centricity Enterprise Archive software recalled for patient data misassociation risk
What this means
GE Healthcare's Centricity Enterprise Archive software (versions V2–V4) can incorrectly link historical medical images to the wrong patient during data migration from older systems. If this occurs, a doctor may view or rely on imaging that belongs to another patient, potentially leading to wrong diagnoses or delayed care.
- Contact GE Healthcare if your facility uses Centricity Enterprise Archive to discuss available fixes or updates
- Review your data migration processes and verify patient records, especially for recently migrated imaging data
- Alert your clinical team to double-check patient identities before relying on migrated imaging studies
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3166-2026More GE Healthcare recalls
- FDA-Device2026-09-23GE Healthcare Enterprise Archive V8 software recalled for patient data association errors
- FDA-Device2026-09-23GE Healthcare Workflow Core Services V8 recalled for patient data mix-up risk
- FDA-Device2026-09-23GE Healthcare Core Services Hub V8 recalled for patient data misassociation risk
- FDA-Device2026-09-23GE Healthcare Centricity PACS software recalled for patient data mix-up risk
- FDA-Device2026-09-23GE Healthcare Centricity PACS Server V7 recalled for patient data mislabeling risk
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