GE HealthCare is recalling 826 units of its Versana Premier R3 and LOGIQ F R3 series ultrasound systems due to a software error in the Estimated Fetal Weight measurement feature. The systems may display previous obstetric patient data in the current patient's "Whizz" report. This inaccuracy can lead to errors in calculating the size and growth of a fetus, which could result in incorrect medical decisions by clinicians. No incidents or injuries have been reported at this time.
The device may show measurement data from a previous patient instead of the current one, leading to an incorrect assessment of fetal size and health. This poses a risk of clinicians making the wrong diagnosis or clinical decision regarding a pregnancy's progress.
Diagnostic ultrasound system
Includes veterinary and specialty expert versions
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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