FDA-Device2025-12-24Class II

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

GE Healthcare GmbH
Hazard

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.

Sold states
Worldwide
Affected count
1221 units
Manufactured in
Oskar-Schlemmer-Str. 11, Munich, Germany
Products
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2026

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