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LOGIQ recallZ-2029-2025 · GE Medical Systems China Co., Ltd. · initiated May 16, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems China Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design (manufacturing process)

What the company is doing

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.

Recall details

Recall number
Z-2029-2025
Status
Open, Classified
Initiated by the company
May 16, 2025
Posted by the FDA
Jun 26, 2025
Recalling firm
GE Medical Systems China Co., Ltd.
Quantity
34 units
Product code
IYN
FDA submissions
K242005
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K242005 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96992).

Sources and updates

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