{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1017-2026.jsonld", "@type": "schema:Dataset", "name": "VANTAGE GALAN 3T Model MRT-3020/MEXL-3020", "description": "FDA recall Z-1017-2026 — Canon Medical System, USA, INC. is recalling VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1017-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "VANTAGE GALAN 3T Model MRT-3020/MEXL-3020", "manufacturer": { "@type": "schema:Organization", "name": "Canon Medical System, USA, INC." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1017-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1017-2026: Canon Medical System, USA, INC. is recalling VANTAGE GALAN 3T Model MRT-3020/MEXL-3020", "text": "The FDA logged enforcement record Z-1017-2026: Canon Medical System, USA, INC. is voluntarily recalling VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 — 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-19. Affected lots/codes: Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010 MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005 MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008 MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007 MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009 MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011 MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008 MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010 MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004 MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005 MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014 MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003 MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012 MRT-3020/A5 MEXL-3020/D5 D5A2062003 30053897 (01)04987670102615(21)A5D2062015 MRT-3020/A5 MEXL-3020/S5 S5C18Y2048 30056987 (01)04987670102615(21)A5C18Y2013 MRT-3020/A5 MEXL-3020/D5 D5D23X2032 30087647 (01)04987670102615(21)A5G23X2017 MRT-3020/A5 MEXL-3020/D5 D5C2292024 30087649 (01)04987670102615(21)A5F2292016 MRT-3020/A5 MEXL-3020/S5.004 S5A1662001 30092401 (01)04987670102615(21)A5A1662001 MRT-3020/A6 MEXL-3020/D7 D7B2152015 30056208 (01)04987670102615(21)A6D2152001 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 (01)04987670102615(21)A7B1892001 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 (01)04987670102615(21)A7D2182004 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 (01)04987670102615(21)A7B1962002 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571 (01)04987670102615(21)A7B1992003 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1017-2026&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1017-2026&lang=eng" } }, "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1017-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1017-2026 as Class II", "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1017-2026&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1017-2026&lang=eng" } }, "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1017-2026/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1017-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1017-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Canon Medical System, USA, INC.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "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.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-12-19", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010 MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005 MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008 MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007 MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009 MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011 MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008 MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010 MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004 MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005 MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014 MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003 MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012 MRT-3020/A5 MEXL-3020/D5 D5A2062003 30053897 (01)04987670102615(21)A5D2062015 MRT-3020/A5 MEXL-3020/S5 S5C18Y2048 30056987 (01)04987670102615(21)A5C18Y2013 MRT-3020/A5 MEXL-3020/D5 D5D23X2032 30087647 (01)04987670102615(21)A5G23X2017 MRT-3020/A5 MEXL-3020/D5 D5C2292024 30087649 (01)04987670102615(21)A5F2292016 MRT-3020/A5 MEXL-3020/S5.004 S5A1662001 30092401 (01)04987670102615(21)A5A1662001 MRT-3020/A6 MEXL-3020/D7 D7B2152015 30056208 (01)04987670102615(21)A6D2152001 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 (01)04987670102615(21)A7B1892001 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 (01)04987670102615(21)A7D2182004 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 (01)04987670102615(21)A7B1962002 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571 (01)04987670102615(21)A7B1992003 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.", "Status": "recorded" } } ] } ] }