# FDA recall Z-0935-2026

> **GE Healthcare GmbH** · Class II · device recall initiated 2025-11-03.

## 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.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0935-2026
- **Recalling firm:** GE Healthcare GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-03
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2026

## Citation

> AI Analytics. FDA recall Z-0935-2026. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0935-2026. Source: US FDA. Licensed CC0.

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