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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0446-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear",
  "description": "FDA recall Z-0446-2024 — Elekta, Inc. is recalling ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear (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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    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0446-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Elekta, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0446-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0446-2024: Elekta, Inc. is recalling ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear",
      "text": "The FDA logged enforcement record Z-0446-2024: Elekta, Inc. is voluntarily recalling ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear — reason: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms.  When the detector arm is fully deployed there is no risk of uncontrolled extension.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-25. Affected lots/codes: UDI/DI 05060191071512, Serial Numbers:  153451, 154067, 154072, 153600, 153693, 152596, 152649, 152834, 152956, 152957, 153005, 153054, 153377, 153593, 153602, 153617, 153852, 154048, 154049, 154060, 152971, 152597, 151995, 153685, 154560, 153748, 153979, 153989, 152902, 153670, 152937, 153198, 151839, 151942, 151958, 151959, 151961, 152019, 152103, 152115, 152158, 152207, 152210, 152211, 152223, 152257, 152303, 152364, 152371, 152504, 152520, 152585, 152593, 152604, 152652, 152659, 152715, 152732, 152801, 152802, 152817, 152818, 152828, 152833, 152916, 152927, 152946, 152963, 152970, 152993, 153035, 153046, 153071, 153138, 153141, 153143, 153164, 153200, 153230, 153375, 153450, 153474, 153529, 153534, 153542, 153558, 153727, 153746, 153753, 153761, 153794, 153803, 153824, 153826, 153840, 153871, 153915, 153939, 154051, 154093, 154132, 154135, 154169, 154175, 154204, 154206, 154224, 154242, 154244, 154264, 154312, 154378, 154380, 154422, 154429, 154453, 154536, 154558;    UDI/DI 05060191071543, Serial Numbers:  153741, 154363, 152506, 152768, 152969, 153004, 153047, 153048, 153120, 153121, 152478, 152772, 153303, 153402, 153626, 152668, 152669, 152692, 152853, 152979, 152984, 153015, 153017, 153053, 153308, 153802, 154065, 153946, 153960, 154082, 154130, 154144, 154189, 154229, 154289, 154290, 154302, 154311, 154414, 154423, 154475, 153472, 152888, 153298, 154277, 154297, 154310, 154355, 154434, 151044, 152554, 153076, 153237, 153324, 153586, 153961, 154211, 154403, 154231, 153441, 153236, 153511, 153646, 153652, 153655, 153674, 153677, 153845, 153869, 153982, 154134, 154159, 154208, 154209, 154213, 152996, 153010, 153052, 153285, 153288, 153294, 153792, 153799, 154115, 154467, 153350, 153866, 152370, 153878, 154366, 154582, 153933, 153001, 154181, 154205, 153531, 153631, 153692, 153743, 153987, 154045, 154468, 152709, 153615, 153103, 153332, 153907, 153091, 152031, 152163, 152175, 152192, 152200, 152222, 152388, 152392, 152432, 152469, 152481, 152491, 152502, 152556, 152599, 152601, 152618, 152673, 152784, 152792, 152798, 152955, 152959, 153019, 153021, 153032, 153036, 153050, 153061, 153068, 153114, 153136, 153253, 153282, 153319, 153321, 153342, 153354, 153429, 153442, 153448, 153464, 153491, 153493, 153535, 153536, 153548, 153597, 153598, 153681, 153719, 153738, 153749, 153798, 154069, 154117, 154182, 154319, 154387, 154485, 154504, 154512, 154535, 154565, 154265. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-0446-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0446-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0446-2024 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
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      "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-0446-2024&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-0446-2024&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-0446-2024/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."
    }
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      "name": "FDA recall details — Z-0446-2024",
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            "Value": "Z-0446-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Elekta, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms.  When the detector arm is fully deployed there is no risk of uncontrolled extension.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-10-25",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI/DI 05060191071512, Serial Numbers:  153451, 154067, 154072, 153600, 153693, 152596, 152649, 152834, 152956, 152957, 153005, 153054, 153377, 153593, 153602, 153617, 153852, 154048, 154049, 154060, 152971, 152597, 151995, 153685, 154560, 153748, 153979, 153989, 152902, 153670, 152937, 153198, 151839, 151942, 151958, 151959, 151961, 152019, 152103, 152115, 152158, 152207, 152210, 152211, 152223, 152257, 152303, 152364, 152371, 152504, 152520, 152585, 152593, 152604, 152652, 152659, 152715, 152732, 152801, 152802, 152817, 152818, 152828, 152833, 152916, 152927, 152946, 152963, 152970, 152993, 153035, 153046, 153071, 153138, 153141, 153143, 153164, 153200, 153230, 153375, 153450, 153474, 153529, 153534, 153542, 153558, 153727, 153746, 153753, 153761, 153794, 153803, 153824, 153826, 153840, 153871, 153915, 153939, 154051, 154093, 154132, 154135, 154169, 154175, 154204, 154206, 154224, 154242, 154244, 154264, 154312, 154378, 154380, 154422, 154429, 154453, 154536, 154558;    UDI/DI 05060191071543, Serial Numbers:  153741, 154363, 152506, 152768, 152969, 153004, 153047, 153048, 153120, 153121, 152478, 152772, 153303, 153402, 153626, 152668, 152669, 152692, 152853, 152979, 152984, 153015, 153017, 153053, 153308, 153802, 154065, 153946, 153960, 154082, 154130, 154144, 154189, 154229, 154289, 154290, 154302, 154311, 154414, 154423, 154475, 153472, 152888, 153298, 154277, 154297, 154310, 154355, 154434, 151044, 152554, 153076, 153237, 153324, 153586, 153961, 154211, 154403, 154231, 153441, 153236, 153511, 153646, 153652, 153655, 153674, 153677, 153845, 153869, 153982, 154134, 154159, 154208, 154209, 154213, 152996, 153010, 153052, 153285, 153288, 153294, 153792, 153799, 154115, 154467, 153350, 153866, 152370, 153878, 154366, 154582, 153933, 153001, 154181, 154205, 153531, 153631, 153692, 153743, 153987, 154045, 154468, 152709, 153615, 153103, 153332, 153907, 153091, 152031, 152163, 152175, 152192, 152200, 152222, 152388, 152392, 152432, 152469, 152481, 152491, 152502, 152556, 152599, 152601, 152618, 152673, 152784, 152792, 152798, 152955, 152959, 153019, 153021, 153032, 153036, 153050, 153061, 153068, 153114, 153136, 153253, 153282, 153319, 153321, 153342, 153354, 153429, 153442, 153448, 153464, 153491, 153493, 153535, 153536, 153548, 153597, 153598, 153681, 153719, 153738, 153749, 153798, 154069, 154117, 154182, 154319, 154387, 154485, 154504, 154512, 154535, 154565, 154265",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "worldwide",
            "Status": "recorded"
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}