{
  "@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-0195-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.  11105200",
  "description": "FDA recall Z-0195-2024 — Siemens Medical Solutions USA, Inc is recalling Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.  11105200 (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-0195-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.  11105200",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Siemens Medical Solutions USA, Inc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0195-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0195-2024: Siemens Medical Solutions USA, Inc is recalling Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.  11105200",
      "text": "The FDA logged enforcement record Z-0195-2024: Siemens Medical Solutions USA, Inc is voluntarily recalling Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.  11105200 — reason: Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-12. Affected lots/codes: ***Updated 12/4/23*** UDI-DI: 04056869153490 S/N:  40013 40014 40015 40018 40020 40023 40030 40032 40033 40034 40035 40036 40039 40040 40046 40047 40048 40049 40050 40051 40052 40054 40055 40057 40058 40062 40070 40073 40075 40076 40077 40078 40080 40083 40084 40093 40094 40095 40102 40103 40104 40107 40108 40109 40110 40111 40116 40117 40119 40121 40122 40123 40124 40125 40126 40130 40134 40135 40137 40139 40157 40158 40160 40161 40162 40163 40164 40167 40168 40169 40170 40171 40174 40175 40176 40188 40189 40190 40191 40192 40193 40194 40196 40206 40208 40215 40220 40226 40228 40230 40231 40234 40236 40238 40239 40240 40242 40244 40245 40246 40248 40250 40251 40252 40255 40256 40257 40259 40261 40263 40264 40265 40266 40267 40268 40270 40271 40273 40276 40314 40315 40317 40318 40322 40323 40324 40336 40339 42001 42002 42003 42004 42005 42006 42010 42018 42024 42025 42028 42032 42033 42037 42040 42041 42042 42045 42046 42052 42057 42061 42068 42069 42082 42087 42094 42101 42111 42140 42141 42146 42147 42148 42156 42160 42161 42185 42186 42187 42188 42189 42190 42191 42196 42199 42202 43000 43002 43003 43006 43007 43013 43022 43023 43025 43026 43027 43028 43029 43031 43033 43034 43037 43042 43044 43045 43046 43048 43049 43055 43058 43060 43061 43062 43063 43072 43073 43076 43079 43086 43095 43105 43106 43108 43112 43142 43143 43150 43161 43163 43177 43193 43208 43222 43226 43231 43257 43261 43279 43283 43286 43289 43291 43296 43297 43298 43319 43339. 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-0195-2024&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-0195-2024&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-0195-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0195-2024 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-0195-2024&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-0195-2024&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-0195-2024/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-0195-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0195-2024",
            "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": "Siemens Medical Solutions USA, Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-09-12",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "***Updated 12/4/23*** UDI-DI: 04056869153490 S/N:  40013 40014 40015 40018 40020 40023 40030 40032 40033 40034 40035 40036 40039 40040 40046 40047 40048 40049 40050 40051 40052 40054 40055 40057 40058 40062 40070 40073 40075 40076 40077 40078 40080 40083 40084 40093 40094 40095 40102 40103 40104 40107 40108 40109 40110 40111 40116 40117 40119 40121 40122 40123 40124 40125 40126 40130 40134 40135 40137 40139 40157 40158 40160 40161 40162 40163 40164 40167 40168 40169 40170 40171 40174 40175 40176 40188 40189 40190 40191 40192 40193 40194 40196 40206 40208 40215 40220 40226 40228 40230 40231 40234 40236 40238 40239 40240 40242 40244 40245 40246 40248 40250 40251 40252 40255 40256 40257 40259 40261 40263 40264 40265 40266 40267 40268 40270 40271 40273 40276 40314 40315 40317 40318 40322 40323 40324 40336 40339 42001 42002 42003 42004 42005 42006 42010 42018 42024 42025 42028 42032 42033 42037 42040 42041 42042 42045 42046 42052 42057 42061 42068 42069 42082 42087 42094 42101 42111 42140 42141 42146 42147 42148 42156 42160 42161 42185 42186 42187 42188 42189 42190 42191 42196 42199 42202 43000 43002 43003 43006 43007 43013 43022 43023 43025 43026 43027 43028 43029 43031 43033 43034 43037 43042 43044 43045 43046 43048 43049 43055 43058 43060 43061 43062 43063 43072 43073 43076 43079 43086 43095 43105 43106 43108 43112 43142 43143 43150 43161 43163 43177 43193 43208 43222 43226 43231 43257 43261 43279 43283 43286 43289 43291 43296 43297 43298 43319 43339",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}