GE Medical Systems China Co., Ltd.: Medical Device Recall in 2025 - (Recall #: Z-2029-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 16, 2025

Date Posted: July 2, 2025

Recall Number: Z-2029-2025

Event ID: 96992

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.

Status: Ongoing

Product Quantity: 34 units

Code Information:

UDI/DI 00195278722430, Lot/Serial Numbers: 6310028WX0, 6310008WX0, 6310041WX0, 6310017WX0, 6310031WX0, 6310044WX0, 6310024WX0, 6310038WX0, 6310040WX0, 6310019WX0, 6310018WX0, 6310023WX0, 6310033WX0, 6310012WX0, 6310026WX0, 6310020WX0, 6310032WX0, 6310014WX0, 6310021WX0, 6310025WX0, 6310010WX0, 6310027WX0, 6310037WX0, 6310009WX0, 6310007WX0, 6310035WX0, 6310016WX0, 6310039WX0, 6310036WX0, 6310043WX0, 6310011WX0, 6310015WX0, 6310013WX0, 6310029WX0.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated