Official recall record
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-31
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00195278409287
- Brand on record
- GE Healthcare
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-29.
Record last checked against the registry on 2026-09-29.
Other recalls from this brand
- 2026-07-31 · US FDA — Medical Devices
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exam - 2026-07-31 · US FDA — Medical Devices
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, - 2026-07-31 · US FDA — Medical Devices
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) servic
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