Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2029-2025 — GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

U.S. FDA — Device Enforcement · China · 2025-05-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2029-2025
Date of alert
2025-05-16
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems China Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278722430
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.