GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 03, 2025 |
| Reported | December 24, 2025 |
| Recalling firm | GE Healthcare GmbH |
| Country / region | Germany Worldwide |
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.
Affected products
- GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
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