Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Evidence summary

The K230355 FDA decision summary identifies the Vantage Galan 3T, MRT-3020, and V9.0 with AiCE Reconstruction Processing Unit and documents that the modification did not change the cleared intended use or indications. Software, image-quality, phantom, and system verification supports the release-specific reconstruction workflow; it does not establish a universal clinical sensitivity or specificity claim.

FDA 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 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K230355. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-1017-2026 is Open, Classified for VANTAGE GALAN 3T Model MRT-3020/MEXL-3020. FDA reason: There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room. FDA action: On 12/19/2025, the firm sent via Adobe DocuSign an "Urgent: Medical Device Correction" letter to customers informing them that It has been discovered that in the superconducting magnet used in the applicable system, if there is slow leakage, over a long period of time, of refrigerant gas from the superconducting magnet, air ingress into the helium vessel via the leak point may result in ice forming. If this is left unchecked, the worst-case scenario is that the helium gas will not be able to escape through the designed exhaust path, and the helium tank could eventually rupture, releasing helium gas into the MR scan room. For safety management of the superconducting magnet, the status of the magnet is checked during maintenance inspections and continuously monitored by a remote monitoring system. However, in response to the above report from the manufacturer of the superconducting magnet, an inspection to check for slow gas leaks in the superconducting magnet used in systems installed at our customer sites will be provided as a repair service. Note that there have been no reports of health hazards related to this incident. Customer are instructed to: The system can continue to be used. However, please ensure there are adequate evacuation routes from the scan/imaging room and the control room. Additionally, do not press the quench button in cases other than emergencies. A representative of Canon Medical Systems USA will contact you to schedule an inspection. If you have any questions regarding this matter, please contact your service representative. Share the contents of letter with all users and reviewing radiologist as well as clinical engineering or... FDA recall Z-2041-2024 is Open, Classified for MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020). FDA reason: The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire. FDA action: On 5/10/24, correction notices were sent to customers who were asked to do the following: 1) The replacement of the power cable securing parts that may cause smoke and fire, with parts made of materials with a higher degree of flame retardance, is now being released. 2) A firm representative will contact you to schedule a time to replace the power cable securing parts. 3) If any abnormalities such as unusual smells or smoke are observed before the work, immediately stop using the system and contact your service representative. 4) The parts required to address the defect are expected to be available no earlier than June 2024. 5) Complete and return the reply form via DocuSign or via email to pbiggins@us.medical.canon For questions, please contact our InTouch team at intouchdispatch@us.medical.canon

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 exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-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, 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 decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 0 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision summary K230355: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR U.S. Food and Drug Administration · 2026-09-03
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-1017-2026: VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2041-2024: MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020) 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
• Canon Vantage Galan 3T Canon Medical Systems · 2026-09-03