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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0433-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: Leksell Stereotactic System  Product Name: Leksell Vantage Stereotactic System  Software Version: n/a  Product Description: The Intended Purpose of Leksell¿ Vantage\" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.",
  "description": "FDA recall Z-0433-2026 — Elekta, Inc. is recalling Brand Name: Leksell Stereotactic System  Product Name: Leksell Vantage Stereotactic System  Software Version: n/a  Product Description: The Intended Purpose of Leksell¿ Vantage\" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments. (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0433-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Leksell Stereotactic System  Product Name: Leksell Vantage Stereotactic System  Software Version: n/a  Product Description: The Intended Purpose of Leksell¿ Vantage\" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Elekta, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0433-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0433-2026: Elekta, Inc. is recalling Brand Name: Leksell Stereotactic System  Product Name: Leksell Vantage Stereotactic System  Software Version: n/a  Product Description: The Intended Purpose of Leksell¿ Vantage\" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.",
      "text": "The FDA logged enforcement record Z-0433-2026: Elekta, Inc. is voluntarily recalling Brand Name: Leksell Stereotactic System  Product Name: Leksell Vantage Stereotactic System  Software Version: n/a  Product Description: The Intended Purpose of Leksell¿ Vantage\" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments. — reason: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-30. Affected lots/codes: Lot Code: UDI References: Arc: 07340048304856  Support Arc: 07340048304849  Arcs and Support Arcs with Serial Numbers: SH00001-SH00338. 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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        "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-0433-2026&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-0433-2026&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0433-2026/fda-classification",
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      "name": "FDA classified recall Z-0433-2026 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.",
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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-0433-2026&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-0433-2026/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,
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        "adjudged": false,
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      "grounding": {
        "groundingType": "Interpretation",
        "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-0433-2026",
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            "Value": "Z-0433-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Elekta, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-30",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: UDI References: Arc: 07340048304856  Support Arc: 07340048304849  Arcs and Support Arcs with Serial Numbers: SH00001-SH00338",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of  Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
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}