SIGNA Premier

Evidence summary

Exact-submission evidence is limited to manufacturer verification, validation, simulated-use testing, and internal scans summarized by FDA. The review did not identify an independent peer-reviewed study or registered trial that could be confidently mapped to the K183231 AIRx implementation.

• FDA source
• Exact FDA submission
• Checked 2026-09-02

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

Postmarket safety review

FDA recall Z-1767-2026 includes SIGNA Premier systems that may contain ferrous steel fittings at the rear of the magnet instead of non-ferrous brass fittings, creating a personnel-injury risk if the rear is serviced while the magnet is ramped. FDA lists the recall as open and classified. FDA recall Z-2304-2025 includes SIGNA Premier systems for which planned maintenance may not have checked patient-table caster-lock function, allowing an undocked table to move during patient transfer. FDA lists the recall as open and classified. FDA recall Z-2462-2024 includes SIGNA Premier software RX27.0-RX27.3, RX28.0, RX29.0-RX29.2, MR30.0, and MR30.1. Under specified Low SAR and 2D T2 FLAIR settings, predicted B1+RMS can exceed the prescribed limit and overheat an MR-conditional implant. FDA lists the recall as open and classified. FDA recall Z-1430-2022 affects SIGNA Premier model 5748519 because rare gradient-coil conditions could produce elevated acoustic noise and prolonged exposure could lead to hearing loss. FDA lists the recall as open and classified. FDA recall Z-0590-2022 includes the superconducting magnet used in SIGNA Premier systems because the cryogen ventilation system may not meet venting requirements. FDA lists the recall as open and classified. FDA recall Z-0132-2022 affected SIGNA Premier because some slices could be missing under certain conditions, creating a gap in anatomy in three-dimensional volume images. FDA lists the recall as terminated. FDA recall Z-2052-2021 affected SIGNA Premier because a user intending to select Save RX could inadvertently select Patient Orientation before the initial three-plane localizer, potentially producing incorrectly annotated or flipped images. FDA lists the recall as open and classified.

• FDA source
• Exact FDA submission
• 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.

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• Verify security and privacy controls: No exact K183231-era cybersecurity architecture, MDS2, supported operating-system inventory, patch policy, remote-service controls, audit specification, or vulnerability-management document was established from the reviewed public sources.
• Verify local validation and lifecycle monitoring: No public exact-version operational-monitoring specification was established. A local program should track AIRx prescription overrides and errors, repeat and aborted scans, protocol drift, image-quality complaints, DICOM failures, downtime, service actions, hearing-protection and MR safety controls, software versions, and open recall corrections.

The refreshed discovery snapshot contains 12 PubMed and 6 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 12 PubMed and 6 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 7 FDA recall candidates were manually reviewed: 7 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 7 postmarket candidate records; 7 have been reviewed (7 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, peer reviewed publication, trial registry, vendor product page, vendor interoperability, vendor pricing observation, reimbursement policy, fda device recall, fda decision summary packet, literature index, pubmed, clinical trials, openfda device recall