Class II

Medical Device Recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

GE Healthcare GmbH · November 3, 2025

Reason for Recall

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.

Distribution

Worldwide

Quantity Affected

1221 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0935-2026

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.