# FDA recall Z-2029-2025

> **GE Medical Systems China Co., Ltd.** · Class II · device recall initiated 2025-05-16.

## Product

GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

## Reason for recall

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the  Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2029-2025
- **Recalling firm:** GE Medical Systems China Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-16
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wuxi, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2025

## Citation

> AI Analytics. FDA recall Z-2029-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2029-2025. Source: US FDA. Licensed CC0.

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