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Medical Device

Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions

Recall date: 2026-09-23 · Source: FDA_DEVICE
Brand / Firm
GE Healthcare
Product
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Reason for recall
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.
Units affected
1298 systems
Description
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
View official recall notice →