FDA recall Z-0935-2026

GE Healthcare GmbH · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-11-03
Report date: 2025-12-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Munich, Germany

Primary source

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