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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3125-2024.jsonld",
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  "name": "Brand Name: PROBEAT  Product Name: PROBEAT-FR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton   beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose,   dose distribution and directed to the prescribed patient treatment site.  Component: N/A",
  "description": "FDA recall Z-3125-2024 — Hitachi America, Ltd., Particle Therapy Division is recalling Brand Name: PROBEAT  Product Name: PROBEAT-FR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton   beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose,   dose distribution and directed to the prescribed patient treatment site.  Component: N/A (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3125-2024&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: PROBEAT  Product Name: PROBEAT-FR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton   beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose,   dose distribution and directed to the prescribed patient treatment site.  Component: N/A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Hitachi America, Ltd., Particle Therapy Division"
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3125-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3125-2024: Hitachi America, Ltd., Particle Therapy Division is recalling Brand Name: PROBEAT  Product Name: PROBEAT-FR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton   beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose,   dose distribution and directed to the prescribed patient treatment site.  Component: N/A",
      "text": "The FDA logged enforcement record Z-3125-2024: Hitachi America, Ltd., Particle Therapy Division is voluntarily recalling Brand Name: PROBEAT  Product Name: PROBEAT-FR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton   beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose,   dose distribution and directed to the prescribed patient treatment site.  Component: N/A — reason: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-27. Affected lots/codes: Lot Code: UDI:(01)04560333350204(11)240112(21)PTFR-01. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3125-2024&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-3125-2024&lang=eng"
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      },
      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3125-2024/fda-classification",
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      "name": "FDA classified recall Z-3125-2024 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.",
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        "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-3125-2024&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-3125-2024/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": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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."
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      "name": "FDA recall details — Z-3125-2024",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "Hitachi America, Ltd., Particle Therapy Division",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.",
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            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of TN, TX, and WA.",
            "Status": "recorded"
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