Recall Z-0935-2026— GE Healthcare GmbH
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare GmbH, initiated 2025-11-03. It names one FDA 510(k) clearance: K241300. Product: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system. 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
- GE Healthcare GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-03
- Firm location
- Munich, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.