SIGNA Artist

Evidence summary

K202238 describes manufacturer AIR Recon DL reconstruction and system testing. Public family materials support current implementation context; reviewed recalls cover missing slices, cryogen venting, orientation, table caster locks, and Low-SAR B1+RMS behavior rather than a single common AI failure mode.

Public source Exact FDA submission Checked 2026-09-03

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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

5 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K202238. Read the model- and version-scoped events and confirm affected-unit and correction status with the manufacturer. FDA recall Z-0139-2022 affected SIGNA Artist because some slices could be missing and leave a gap of anatomy in three-dimensional volume images. FDA lists the recall as terminated. FDA recall Z-0600-2022 includes superconducting magnets used in SIGNA Artist systems whose cryogen ventilation might not meet venting requirements. FDA lists the recall as open and classified. FDA recall Z-2061-2021 affected SIGNA Artist because an unintended patient-orientation change before the initial localizer could produce incorrectly annotated or flipped images. FDA lists the recall as open and classified. FDA recall Z-2299-2025 includes SIGNA Artist patient tables because planned maintenance might omit checks of caster-lock function, allowing movement during patient transfer. FDA lists the recall as open and classified. FDA recall Z-2469-2024 includes SIGNA Artist software DV26.0 through MR30.1 because predicted B1+RMS could exceed the prescribed Low SAR limit for specified FLAIR configurations and overheat an MR-conditional implant. 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: 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.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 5 FDA recall candidates were manually reviewed: 5 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 5 postmarket candidate records; 5 have been reviewed (5 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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

• K202238 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-0139-2022: SIGNA Artist nuclear magnetic resonance imaging system U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-0600-2022: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2061-2021: SIGNA Artist, Nuclear Magnetic Resonance Imaging System U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2299-2025: GE Signa Artist, Nuclear Magnetic Resonance Imaging System U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2469-2024: SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System U.S. Food and Drug Administration · 2026-09-04
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• GE HealthCare AIR Recon DL GE HealthCare · 2026-09-03
• SIGNA Artist 1.5T wide-bore MRI system GE HealthCare · 2026-09-03