GE HealthCare ViewPoint 6 — Class II medical device recall Z-0935-2026
Ongoing recall by GE Healthcare GmbH, reported 2025-12-24. GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasou
| Recall number | Z-0935-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare GmbH, Munich, Germany |
| Recall initiated | 2025-11-03 |
| Classified | 2025-12-16 |
| Reported by FDA | 2025-12-24 |
| Quantity | 1,221 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00195278753472 |
| Model numbers | H47601AA |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0935-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.