FDA Recall: Patient history tab may not contain complete patient history

Company: GE Healthcare GmbH
Date of Enforcement Report: 12/16/2025
Class: II

PRODUCT

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

Recall Number:

Z-0935-2026

REASON:

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.

RECALLING FIRM/MANUFACTURER:

GE Healthcare GmbH

VOLUME:

1208 units

DISTRIBUTION:

Worldwide

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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