# FDA recall Z-1556-2025

> **GE Medical Systems, LLC** · Class II · device recall initiated 2025-03-06.

## Product

Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems

## Reason for recall

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1556-2025
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-06
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1556-2025

## Citation

> AI Analytics. FDA recall Z-1556-2025. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1556-2025. Source: US FDA. Licensed CC0.

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