The Recall Desk
HighFDA (Devices)·Z-2030-2025·Announced 2025-07-02

GE Healthcare Versana Ultrasound Systems display incorrect fetal weight data

GE Healthcare Versana Premier R3 and LOGIQ F R3 ultrasound systems can display previous obstetric patient data in fetal weight measurement reports, potentially leading to incorrect clinical decisions based on inaccurate fetal size and growth calculations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving risk of incorrect clinical decision-making due to display of wrong patient data in obstetric measurements. Although no reported illnesses or injuries are stated in the source, the potential for serious harm in obstetric care (fetal assessment errors affecting clinical management) meets the threshold for High severity under the rubric for "risk-of-harm products where injury has not yet been reported."

Plain-English summary

GE Healthcare has identified a defect in the Estimated Fetal Weight (EFW) measurement data feature on Versana Premier R3 and LOGIQ F R3 series ultrasound systems. The systems can display previous obstetric patient data in the Whizz report, which may not correspond to the current patient being examined.

This data display error could potentially lead to incorrect clinical decisions because physicians may rely on inaccurate fetal size and growth calculations. The recall affects Versana Premier R3 and related models distributed worldwide, manufactured by GE Medical Systems China Co., Ltd. A total of 792 units are affected.

Affected facilities and healthcare providers should review any fetal weight reports generated on these systems and verify that the data displayed corresponds to the correct current patient before making clinical decisions based on the measurements.

The recalled product

Product
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560;
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Diagnostic Ultrasound Systems
Hazard
  • incorrect-measurement
  • data-display-error
  • patient-data-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model/Catalog Number 5938558
  • UDI/DI (01)00195278690388(11)241127(21)6302036WX0
  • Lot/Serial Number 6302036WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302045WX0
  • Lot/Serial Number 6302045WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302035WX0
  • Lot/Serial Number 6302035WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302046WX0
  • Lot/Serial Number 6302046WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302033WX0
  • Lot/Serial Number 6302033WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302034WX0
  • Lot/Serial Number 6302034WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302041WX0
  • Lot/Serial Number 6302041WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302040WX0
  • Lot/Serial Number 6302040WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302039WX0
  • Lot/Serial Number 6302039WX0
  • UDI/DI (01)00195278690388(11)241127(21)6302044WX0

Distribution

Distribution scope not specified by the agency.

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