GE Healthcare Enterprise Archive V8 software recalled for patient data association errors
What this means
GE Healthcare's Enterprise Archive V8 software can occasionally link historical imaging data to the wrong patient when migrating from older systems. If this happens, a patient's medical images may appear under another person's record, potentially leading to missed diagnoses or delayed care.
- Contact GE Healthcare immediately if your facility uses Enterprise Archive V8
- Review recent patient records for any imaging data linked during system migration
- Follow GE Healthcare's corrective instructions when provided
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-3167-2026More GE Healthcare recalls
- 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 Enterprise Archive software 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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