Recall Z-0935-2026 ยท LLZ System, Image Processing, Radiological
GE Healthcare GmbH
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
| Date | Dec 16, 2025 (initiated Nov 3, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/3/2025 via letter distributed using a traceable means. The notice explained the issue, safety issue/risk, and requested the following: Actions to be taken by Customer/User: "Pending correction by GE HealthCare, you can continue to use your device by following the instructions below: When creating or opening an exam on ViewPoint 6 version 6.15.3 or ViewPoint 6 version 6.15.4, if using the patient history tab, do not rely on the information. Always confirm that essential patient history data is correc |
| Quantity | 1221 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241300 | ViewPoint 6 Ge Healthcare GmbH, Jul 2, 2024 |