Class II

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

GE Healthcare · July 31, 2026

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.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

1298 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3167-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

GE Healthcare Medical Device Recall: Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions | SafeCheck