Z-2029-2025Class II

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

Name: Z-2029-2025 GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Creator: GE Medical Systems China Co., Ltd.
Published: 2025-05-16
License: https://open.fda.gov/license/

GE Medical Systems China Co., Ltd. / initiated 2025-05-16 / Open, Classified / root cause: software

FDA source

GE Medical Systems China Co., Ltd. began a recall of GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system on 2025-05-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2029-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-16
Posted: 2025-06-26
Recalling firm: GE Medical Systems China Co., Ltd.
Product: GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/16/2025 via letter delivered using a traceable means. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by Customer/User: You may continue to use your Versana Premier R3 and LOGIQ F R3 series ultrasound systems by following the actions below: 1) If you use the Whizz report feature, reboot the system after finishing each obstetric patient examination. OR 2) Instead of using the Whizz report feature, after completing an obstetric patient examination, print all obstetric measurement and calculation results from the worksheet directly. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected]." If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 34 units
Distribution: Worldwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2029-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2029-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-26
Z-2030-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-26

Product code IYN

K242005Class IIVersana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics / cleared 2024-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)