{
  "@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-1846-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Ingenia 1.5T CX  - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):   (1) 781262  (2) 781261",
  "description": "FDA recall Z-1846-2024 — Philips North America Llc is recalling Ingenia 1.5T CX  - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):   (1) 781262  (2) 781261 (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-1846-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Ingenia 1.5T CX  - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):   (1) 781262  (2) 781261",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Philips North America Llc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1846-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1846-2024: Philips North America Llc is recalling Ingenia 1.5T CX  - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):   (1) 781262  (2) 781261",
      "text": "The FDA logged enforcement record Z-1846-2024: Philips North America Llc is voluntarily recalling Ingenia 1.5T CX  - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):   (1) 781262  (2) 781261 — reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-03. Affected lots/codes: UDI-DI:  (1) 781262 (01)00884838068445(21); (2) 781261 (01)00884838068438(21)  Serial Numbers:  Serial Number 77008 77000 77004 77001 77019 77010 77014 77007 77002 77016 77131 77070 77124 77144 77172 77074 77048 77177 77178 77181 77031 77047 77134 77050 77051 77060 77194 77034 77037 77038 77057 77072 77075 77078 77084 77085 77086 77092 77101 77110 77156 77157 77035 77111 77119 77167 77183 77185 77187 77188 77195 77196 77198 77199 77202 77052 77053 77054 77055 77056 77064 77065 77066 77067 77068 77069 77105 77125 77126 77135 77136 77137 77138 77139 77148 77141 77030 77032 77033 77036 77042 77043 77044 77049 77059 77061 77071 77083 77087 77088 77090 77091 77093 77097 77100 77106 77107 77112 77115 77118 77120 77121 77128 77129 77143 77151 77155 77158 77161 77162 77190 77191 77201 77166 77045 77063 77109 77117 77123 77081 77147 77113 77168 77169 77122 77154 77046 77094 77130 77062 77140 77039 77040 77058 77114 77127 77159 77160 77171 77179 77180 77182 77150 77041 77103 77203. 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-1846-2024&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-1846-2024&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-1846-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1846-2024 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-1846-2024&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-1846-2024&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-1846-2024/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-1846-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1846-2024",
            "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": "Philips North America Llc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-03",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI:  (1) 781262 (01)00884838068445(21); (2) 781261 (01)00884838068438(21)  Serial Numbers:  Serial Number 77008 77000 77004 77001 77019 77010 77014 77007 77002 77016 77131 77070 77124 77144 77172 77074 77048 77177 77178 77181 77031 77047 77134 77050 77051 77060 77194 77034 77037 77038 77057 77072 77075 77078 77084 77085 77086 77092 77101 77110 77156 77157 77035 77111 77119 77167 77183 77185 77187 77188 77195 77196 77198 77199 77202 77052 77053 77054 77055 77056 77064 77065 77066 77067 77068 77069 77105 77125 77126 77135 77136 77137 77138 77139 77148 77141 77030 77032 77033 77036 77042 77043 77044 77049 77059 77061 77071 77083 77087 77088 77090 77091 77093 77097 77100 77106 77107 77112 77115 77118 77120 77121 77128 77129 77143 77151 77155 77158 77161 77162 77190 77191 77201 77166 77045 77063 77109 77117 77123 77081 77147 77113 77168 77169 77122 77154 77046 77094 77130 77062 77140 77039 77040 77058 77114 77127 77159 77160 77171 77179 77180 77182 77150 77041 77103 77203",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada,  China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan,  Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia,  Spain, Sweden, Switzerland, Thailand, United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}