Versana Premier LOTUS 5PPRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K242005); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 16, 2025Class IIOpen, Classified

   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.

   Z-2030-2025 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242005. One submission often covers many models, so check the product and lot details in each record.

• Z-2029-2025 · May 16, 2025 · Open, Classified
  GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system