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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1858-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: Catalyst+  Product Name: C4D software used in conjunction with        Catalyst (SP001-0025),   Catalyst HD (SP001-0026),   Catalyst PT (SP001-0027),   Catalyst X4 (SP002-0035),  Catalyst+ (SP003-0001),  Catalyst+ HD (SP003-0002),   Catalyst+ PT (SP003-0008),    Catalyst+ X4, (SPOO3-0009)    Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not a component",
  "description": "FDA recall Z-1858-2025 — C-RAD POSITIONING AB is recalling Brand Name: Catalyst+  Product Name: C4D software used in conjunction with        Catalyst (SP001-0025),   Catalyst HD (SP001-0026),   Catalyst PT (SP001-0027),   Catalyst X4 (SP002-0035),  Catalyst+ (SP003-0001),  Catalyst+ HD (SP003-0002),   Catalyst+ PT (SP003-0008),    Catalyst+ X4, (SPOO3-0009)    Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not a component (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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  "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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1858-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Catalyst+  Product Name: C4D software used in conjunction with        Catalyst (SP001-0025),   Catalyst HD (SP001-0026),   Catalyst PT (SP001-0027),   Catalyst X4 (SP002-0035),  Catalyst+ (SP003-0001),  Catalyst+ HD (SP003-0002),   Catalyst+ PT (SP003-0008),    Catalyst+ X4, (SPOO3-0009)    Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not a component",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "C-RAD POSITIONING AB"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1858-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1858-2025: C-RAD POSITIONING AB is recalling Brand Name: Catalyst+  Product Name: C4D software used in conjunction with        Catalyst (SP001-0025),   Catalyst HD (SP001-0026),   Catalyst PT (SP001-0027),   Catalyst X4 (SP002-0035),  Catalyst+ (SP003-0001),  Catalyst+ HD (SP003-0002),   Catalyst+ PT (SP003-0008),    Catalyst+ X4, (SPOO3-0009)    Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not a component",
      "text": "The FDA logged enforcement record Z-1858-2025: C-RAD POSITIONING AB is voluntarily recalling Brand Name: Catalyst+  Product Name: C4D software used in conjunction with        Catalyst (SP001-0025),   Catalyst HD (SP001-0026),   Catalyst PT (SP001-0027),   Catalyst X4 (SP002-0035),  Catalyst+ (SP003-0001),  Catalyst+ HD (SP003-0002),   Catalyst+ PT (SP003-0008),    Catalyst+ X4, (SPOO3-0009)    Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not a component — reason: Software issue with scanning equipment that can results in the filed rotation not being applied correctly.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-22. Affected lots/codes: All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024;  Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793   Catalyst+ X4 - SP003-0009/UDI: 17350005280809. 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-1858-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1858-2025&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-1858-2025/fda-classification",
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      "name": "FDA classified recall Z-1858-2025 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)",
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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-1858-2025&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-1858-2025/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
      },
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        "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-1858-2025",
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            "Value": "Z-1858-2025",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "C-RAD POSITIONING AB",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Software issue with scanning equipment that can results in the filed rotation not being applied correctly.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-04-22",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024;  Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793   Catalyst+ X4 - SP003-0009/UDI: 17350005280809",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.",
            "Status": "recorded"
          }
        }
      ]
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}