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

[pending] GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers:

Pending LLM rewrite. Source: FDA_DEVICE Z-2030-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

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.

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 — Devices

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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