GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Reported: December 24, 2025 Initiated: November 3, 2025 #Z-0935-2026
Product Description
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.
Details
- Recalling Firm
- GE Healthcare GmbH
- Units Affected
- 1221 units
- Distribution
- Worldwide
- Location
- Munich
Frequently Asked Questions
What product was recalled? ▼
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system. Recalled by GE Healthcare GmbH. Units affected: 1221 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0935-2026.
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