MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

Evidence summary

K250443 describes manufacturer image-quality, reconstruction, feature, safety, software, and interoperability verification. The XA70A education page identifies release-level functions but does not establish local speed or diagnostic-outcome improvements.

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

2 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K250443. Read the model- and version-scoped events and confirm affected-unit and correction status with the manufacturer. FDA recall Z-2661-2025 affects MAGNETOM Skyra fit model 10849580 because ice blockage in the magnet venting system could impede helium escape during a quench. FDA lists the recall as open and classified. FDA recall Z-2662-2025 affects MAGNETOM Skyra Fit BioMatrix model 11516217 because ice blockage in the magnet venting system could impede helium escape during a quench. 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.

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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. 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 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

• K250443 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-2661-2025: MAGNETOM Skyra fit. Model Number: 10849580. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2662-2025: MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. 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
• syngo MR XA70A feature overview Siemens Healthineers Academy · 2026-09-03