Versana Premier; Versana Premier Lotus; LOGIQ F

Evidence summary

K242005 reports nonclinical system, software, probe, DICOM, cleaning, safety, and workflow verification but no clinical study. OpenFDA records Z-2029-2025 and Z-2030-2025 describe a model-specific Whizz Report defect that could carry prior-patient estimated fetal-weight data into a subsequent obstetric report.

• Public source
• Exact FDA submission
• Checked 2026-09-03

• Source
• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

2 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K242005. Read the model- and version-scoped events and confirm affected-unit and correction status with the manufacturer. FDA recall Z-2029-2025 affects specified LOGIQ F R3 systems because the Whizz Report feature could display estimated fetal-weight measurements from the previous obstetric patient, potentially producing inaccurate fetal size or growth calculations. FDA lists the recall as open and classified. FDA recall Z-2030-2025 affects specified Versana Premier R3 configurations because the Whizz Report feature could display estimated fetal-weight measurements from the previous obstetric patient, potentially producing inaccurate fetal size or growth calculations. FDA lists the recall as open and classified.

• FDA source
• Exact product version
• Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

• Source
• Source
• Source

• Verify security and privacy controls: Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

The refreshed discovery snapshot contains 0 PubMed and 2 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 0 PubMed and 2 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 2 FDA recall candidates were manually reviewed: 2 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 2 postmarket candidate records; 2 have been reviewed (2 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall