Medical device recalls Moderate risk

GE Healthcare GmbH recalls GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

Recall date
November 3, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0935-2026
FDA classification
Class II
Brand / firm
GE Healthcare GmbH
Sold / distributed
Worldwide

Why it was recalled

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

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