GE Healthcare recalls Versana Premier ultrasound systems with specific model numbers due to potential incorrect fetal weight calculations in the Estimated Fetal Weight feature, which could lead to inaccurate clinical decisions during pregnancy monitoring.
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.
GE Healthcare is recalling specific models of Versana Premier ultrasound systems because the Estimated Fetal Weight (EFW) measurement feature may display previous obstetric patient data, leading to inaccurate fetal size calculations. This could result in incorrect clinical decisions during pregnancy monitoring.
The EFW feature on these ultrasound systems may display previous obstetric patient data, causing incorrect fetal size and growth calculations. This could lead to inaccurate clinical decisions, such as misjudging the pregnancy's progress or fetal health.
Pregnant individuals using the recalled ultrasound systems for prenatal care are most at risk due to potential inaccuracies in fetal weight measurements. The recall affects specific model numbers and serial numbers.
Check if your ultrasound system has the model numbers listed: Versana Premier R3 VS (5938558), Versana Premier R3 VA (5938559), or other specific variants with the corresponding serial numbers provided in the recall notice.
Verify your ultrasound system's model number and serial number against the list provided in the recall notice to determine if it is affected.
GE Healthcare has identified that the Estimated Fetal Weight (EFW) measurement feature on these ultrasound systems may display previous obstetric patient data, leading to inaccurate fetal size calculations.
Check your model number and serial number against the list of affected units provided in the recall notice.
No specific action is required beyond checking if your system is affected. The recall does not require immediate correction or replacement.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2030-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2030-2025 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
