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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1498-2023.jsonld",
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  "name": "ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-  Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model: 10849000",
  "description": "FDA recall Z-1498-2023 — Siemens Medical Solutions USA, Inc is recalling ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-  Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model: 10849000 (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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    "@type": "schema:MedicalDevice",
    "name": "ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-  Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model: 10849000",
    "manufacturer": {
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      "name": "Siemens Medical Solutions USA, Inc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1498-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1498-2023: Siemens Medical Solutions USA, Inc is recalling ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-  Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model: 10849000",
      "text": "The FDA logged enforcement record Z-1498-2023: Siemens Medical Solutions USA, Inc is voluntarily recalling ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-  Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model: 10849000 — reason: If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If \"Adjust C-arm to Ref\" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message \u001cEndposition reached\u001d will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen    Live images may not match the previously stored reference images.  Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-02. Affected lots/codes: UDI: 04056869046877  S/N: Serial # 164140 164159 164138 164332 164331 164033 164287 164282 164210 164184 164183 164311 164142 164312 164071 164328 164034 164391 164318 164244 164306 164155 164340 164189 164277 164173 164292 164231 164095 164057 164055 164054 164329 164072 164190 164048 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164293 164263 164298 164060 164083 164113 164021 164066 164398 164362 164124 164125 164366 164279 164075 164098 164028 164153 164330 164389 164394 164172 164086 164084 164074 164295 164353 164234 164321 164242 164275 164270 164315 164344 164163 164158 164053 164171 164297 164134 164253 164333 164188 164377 164403 164063 164064 164397 164300 164299 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164399 164011 164211 164216 164204 164205 164212 164100 164097 164269 164303 164322 164355 164400 164196 164352 164168 164319 164201 164202 164371. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "adjudged": true,
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        "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-1498-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1498-2023&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-1498-2023/fda-classification",
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      "name": "FDA classified recall Z-1498-2023 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-1498-2023&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-1498-2023&lang=eng"
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      },
      "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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1498-2023/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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            "Value": "Z-1498-2023",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Value": "Siemens Medical Solutions USA, Inc",
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          "item": {
            "Field": "Reason",
            "Value": "If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If \"Adjust C-arm to Ref\" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message \u001cEndposition reached\u001d will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen    Live images may not match the previously stored reference images.  Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-02-02",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI: 04056869046877  S/N: Serial # 164140 164159 164138 164332 164331 164033 164287 164282 164210 164184 164183 164311 164142 164312 164071 164328 164034 164391 164318 164244 164306 164155 164340 164189 164277 164173 164292 164231 164095 164057 164055 164054 164329 164072 164190 164048 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164293 164263 164298 164060 164083 164113 164021 164066 164398 164362 164124 164125 164366 164279 164075 164098 164028 164153 164330 164389 164394 164172 164086 164084 164074 164295 164353 164234 164321 164242 164275 164270 164315 164344 164163 164158 164053 164171 164297 164134 164253 164333 164188 164377 164403 164063 164064 164397 164300 164299 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164399 164011 164211 164216 164204 164205 164212 164100 164097 164269 164303 164322 164355 164400 164196 164352 164168 164319 164201 164202 164371",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution.",
            "Status": "recorded"
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