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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0704-2025.jsonld",
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  "name": "OEC Elite REF     Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.",
  "description": "FDA recall Z-0704-2025 — GE OEC Medical Systems, Inc is recalling OEC Elite REF     Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures. (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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      "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-0704-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "OEC Elite REF     Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "GE OEC Medical Systems, Inc"
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0704-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0704-2025: GE OEC Medical Systems, Inc is recalling OEC Elite REF     Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.",
      "text": "The FDA logged enforcement record Z-0704-2025: GE OEC Medical Systems, Inc is voluntarily recalling OEC Elite REF     Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures. — reason: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-21. Affected lots/codes: Product Name: OEC Elite GTIN code: 00001234567895 Lot/Serial Numbers / UDI codes: FAXXXE00254 (01)00840682121729(11)190400(21)FAXXXE00254 FBHXTX00837 (01)00840682121729(11)230300(21)FBHXTX00837 FBHXTX00912 (01)00840682121729(11)230500(21)FBHXTX00912 FBHXTX01278 (01)00840682121729(11)240800(21)FBHXTX01278 FBXXXE00731 (01)00840682121729(11)190500(21)FBXXXE00731 FBMHTX00470 (01)00840682121729(11)240900(21)FBMHTX00470 F2XXTX00801 (01)00840682121729(11)240800(21)F2XXTX00801 FBHXXX00171 (01)00840682121729(11)180600(21)FBHXXX00171 FBXXXE00715 (01)00840682121729(11)190500(21)FBXXXE00715 FBMHTX00444 (01)00840682121729(11)240600(21)FBMHTX00444 FBXXTE02974 (01)00840682121729(11)240800(21)FBXXTE02974 FBMHTX00466 (01)00840682121729(11)240900(21)FBMHTX00466 FAXXTE00672 (01)00840682121729(11)221200(21)FAXXTE00672 F9XXTX00276 (01)00840682121729(11)230900(21)F9XXTX00276 FAXXTE01160 (01)00840682121729(11)240800(21)FAXXTE01160 FBMHTX00454 (01)00840682121729(11)240800(21)FBMHTX00454 FBMHTX00455 (01)00840682121729(11)240800(21)FBMHTX00455 FBMHTX00465 (01)00840682121729(11)240900(21)FBMHTX00465 FBXXTE02975 (01)00840682121729(11)240800(21)FBXXTE02975 FBXXTE02976 (01)00840682121729(11)240800(21)FBXXTE02976 FBXXXE00312 (01)00840682121729(11)180900(21)FBXXXE00312 FAXXTE00664 (01)00840682121729(11)221100(21)FAXXTE00664 FBMHTX00450 (01)00840682121729(11)240700(21)FBMHTX00450 FAXXTE01154 (01)00840682121729(11)240700(21)FAXXTE01154 FBXXTE02994 (01)00840682121729(11)240800(21)FBXXTE02994 FAXXTE00544 (01)00840682121729(11)220600(21)FAXXTE00544 FBXXTE01055 (01)00840682121729(11)211200(21)FBXXTE01055 FBXXTE02966 (01)00840682121729(11)240800(21)FBXXTE02966 FBMHTX00467 (01)00840682121729(11)240900(21)FBMHTX00467 FAXXTE00339 (01)00840682121729(11)210600(21)FAXXTE00339 FSXXTX00282 (01)00840682121729(11)220500(21)FSXXTX00282 FAXXXE00231 (01)00840682121729(11)190300(21)FAXXXE00231 FBXXXE00653 (01)00840682121729(11)190400(21)FBXXXE00653 F2XXTX00381 (01)00840682121729(11)220100(21)F2XXTX00381 FBXXXE00008 (01)00840682121729(11)171000(21)FBXXXE00008 FBMHTX00468 (01)00840682121729(11)240900(21)FBMHTX00468 FBXXTP00008 (01)00840682121729(11)240700(21)FBXXTP00008 FSXXTX00501 (01)00840682121729(11)240400(21)FSXXTX00501 F2XXTX00802 (01)00840682121729(11)240800(21)F2XXTX00802 FAXXTE01157 (01)00840682121729(11)240700(21)FAXXTE01157 FBMHTX00447 (01)00840682121729(11)240600(21)FBMHTX00447 FBMHDX00049 (01)00195278096944(11)220100(21)FBMHDX00049 FBXXTE02312 (01)00840682121729(11)230900(21)FBXXTE02312 F9XXTX00301 (01)00840682121729(11)240100(21)F9XXTX00301 FBXXTE02965 (01)00840682121729(11)240800(21)FBXXTE02965 FBXXXE00654 (01)00840682121729(11)190400(21)FBXXXE00654 FBMHTX00452 (01)00840682121729(11)240800(21)FBMHTX00452 FBXXTE00561 (01)00840682121729(11)201100(21)FBXXTE00561 FBXXTE02963 (01)00840682121729(11)240800(21)FBXXTE02963 FBXXTE02109 (01)00840682121729(11)230600(21)FBXXTE02109 FBXXTP00006 (01)00840682121729(11)240700(21)FBXXTP00006 FBXXTP00007 (01)00840682121729(11)240700(21)FBXXTP00007 F2XXTX00021 (01)00840682121729(11)191100(21)F2XXTX00021 FBXXTE02991 (01)00840682121729(11)240800(21)FBXXTE02991 FBXXTE02992 (01)00840682121729(11)240800(21)FBXXTE02992 F2XXTX00799 (01)00840682121729(11)240800(21)F2XXTX00799 FSXXTX00514 (01)00840682121729(11)240600(21)FSXXTX00514 FBXXTE01754 (01)00840682121729(11)230100(21)FBXXTE01754 FBXXTE02914 (01)00840682121729(11)240600(21)FBXXTE02914 FBXXTE00515 (01)00840682121729(11)201000(21)FBXXTE00515 FAXXXE00049 (01)00840682121729(11)180200(21)FAXXXE00049 FBXXXE00272 (01)00840682121729(11)180900(21)FBXXXE00272 FSXXXX00004 (01)00840682121729(11)190400(21)FSXXXX00004 FBMHTX00433 (01)00840682121729(11)240400(21)FBMHTX00433 FBMHTX00446 (01)00840682121729(11)240600(21)FBMHTX00446 FBXXTE01644  (01)00840682121729(11)221200(21)FBXXTE01644 FBMHTX00464 (01)00840682121729(11)240900(21)FBMHTX00464 FBXXTE02978 (01)00840682121729(11)240800(21)FBXXTE02978 F2XXTX00798 (01)00840682121729(11)240800(21)F2XXTX00798 FBXXTE02979 (01)00840682121729(11)240800(21)FBXXTE02979 FBXXTE01932 (01)00840682121729(11)230300(21)FBXXTE01932 FBXXTE02977 (01)00840682121729(11)240800(21)FBXXTE02977 FBXXTE02993 (01)00840682121729(11)240800(21)FBXXTE02993 FBHXTX00821 (01)00840682121729(11)230200(21)FBHXTX00821 F2XXTX00800 (01)00840682121729(11)240800(21)F2XXTX00800 FSXXTX00284 (01)00840682121729(11)220500(21)FSXXTX00284 FBXXTE00575 (01)00840682121729(11)201200(21)FBXXTE00575 FBMHTX00469 (01)00840682121729(11)240900(21)FBMHTX00469 FBXXTE02323 (01)00840682121729(11)230900(21)FBXXTE02323 FSXXTX00422 (01)00840682121729(11)230300(21)FSXXTX00422 FAHXTX00538 (01)00840682121729(11)240600(21)FAHXTX00538 FBXXTE02996 (01)00840682121729(11)240800(21)FBXXTE02996 FSXXTX00418 (01)00840682121729(11)230300(21)FSXXTX00418 FBXXTE01863 (01)00840682121729(11)230300(21)FBXXTE01863 FBMHTX00453 (01)00840682121729(11)240800(21)FBMHTX00453 FBMHTX00329 (01)00840682121729(11)230200(21)FBMHTX00329 FAXXTE01158 (01)00840682121729(11)240800(21)FAXXTE01158 FBXXTE02995 (01)00840682121729(11)240800(21)FBXXTE02995 FAXXTE01159 (01)00840682121729(11)240800(21)FAXXTE01159 F9XXXX00064 (01)00840682121729(11)191200(21)F9XXXX00064 FBXXTE02980 (01)00840682121729(11)240800(21)FBXXTE02980 FBXXTE02981 (01)00840682121729(11)240800(21)FBXXTE02981 FBXXTE02982 (01)00840682121729(11)240800(21)FBXXTE02982 FBXXTE02983 (01)00840682121729(11)240800(21)FBXXTE02983 FBXXTE02984 (01)00840682121729(11)240800(21)FBXXTE02984 FBXXTE02986 (01)00840682121729(11)240800(21)FBXXTE02986 FBXXTE02987 (01)00840682121729(11)240800(21)FBXXTE02987 FBMHTX00456 (01)00840682121729(11)240800(21)FBMHTX00456 FBMHTX00449 (01)00840682121729(11)240700(21)FBMHTX00449 F9XXTX00329 (01)00840682121729(11)240800(21)F9XXTX00329. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0704-2025&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-0704-2025&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-0704-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0704-2025 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)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0704-2025&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-0704-2025&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-0704-2025/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": {
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      "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-0704-2025",
      "numberOfItems": 9,
      "itemListElement": [
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0704-2025",
            "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": "GE OEC Medical Systems, Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product Name: OEC Elite GTIN code: 00001234567895 Lot/Serial Numbers / UDI codes: FAXXXE00254 (01)00840682121729(11)190400(21)FAXXXE00254 FBHXTX00837 (01)00840682121729(11)230300(21)FBHXTX00837 FBHXTX00912 (01)00840682121729(11)230500(21)FBHXTX00912 FBHXTX01278 (01)00840682121729(11)240800(21)FBHXTX01278 FBXXXE00731 (01)00840682121729(11)190500(21)FBXXXE00731 FBMHTX00470 (01)00840682121729(11)240900(21)FBMHTX00470 F2XXTX00801 (01)00840682121729(11)240800(21)F2XXTX00801 FBHXXX00171 (01)00840682121729(11)180600(21)FBHXXX00171 FBXXXE00715 (01)00840682121729(11)190500(21)FBXXXE00715 FBMHTX00444 (01)00840682121729(11)240600(21)FBMHTX00444 FBXXTE02974 (01)00840682121729(11)240800(21)FBXXTE02974 FBMHTX00466 (01)00840682121729(11)240900(21)FBMHTX00466 FAXXTE00672 (01)00840682121729(11)221200(21)FAXXTE00672 F9XXTX00276 (01)00840682121729(11)230900(21)F9XXTX00276 FAXXTE01160 (01)00840682121729(11)240800(21)FAXXTE01160 FBMHTX00454 (01)00840682121729(11)240800(21)FBMHTX00454 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(01)00840682121729(11)220100(21)F2XXTX00381 FBXXXE00008 (01)00840682121729(11)171000(21)FBXXXE00008 FBMHTX00468 (01)00840682121729(11)240900(21)FBMHTX00468 FBXXTP00008 (01)00840682121729(11)240700(21)FBXXTP00008 FSXXTX00501 (01)00840682121729(11)240400(21)FSXXTX00501 F2XXTX00802 (01)00840682121729(11)240800(21)F2XXTX00802 FAXXTE01157 (01)00840682121729(11)240700(21)FAXXTE01157 FBMHTX00447 (01)00840682121729(11)240600(21)FBMHTX00447 FBMHDX00049 (01)00195278096944(11)220100(21)FBMHDX00049 FBXXTE02312 (01)00840682121729(11)230900(21)FBXXTE02312 F9XXTX00301 (01)00840682121729(11)240100(21)F9XXTX00301 FBXXTE02965 (01)00840682121729(11)240800(21)FBXXTE02965 FBXXXE00654 (01)00840682121729(11)190400(21)FBXXXE00654 FBMHTX00452 (01)00840682121729(11)240800(21)FBMHTX00452 FBXXTE00561 (01)00840682121729(11)201100(21)FBXXTE00561 FBXXTE02963 (01)00840682121729(11)240800(21)FBXXTE02963 FBXXTE02109 (01)00840682121729(11)230600(21)FBXXTE02109 FBXXTP00006 (01)00840682121729(11)240700(21)FBXXTP00006 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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.  O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}