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  "name": "GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed",
  "description": "FDA recall Z-1299-2025 — GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed (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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      "name": "FDA recall Z-1299-2025: GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed",
      "text": "The FDA logged enforcement record Z-1299-2025: GE Medical Systems, LLC is voluntarily recalling GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed — reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-18. Affected lots/codes: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN;  System ID Number 205608CT, UDI (01)00840682123471(11)180800(21)REVV81800010CN, Mfg. Lot/Serial Number REVV81800010CN;  System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN;  System ID Number 205699CTREV, UDI Not Applicable, Mfg. Lot/Serial Number 00000442592CN2;  System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN;  System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN;  System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN;  System ID Number 11320, UDI To be provided, Mfg. Lot/Serial Number REVVX2000033CN;  System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN;  System ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN;  System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN;  System ID Number 858824APEX, UDI Not Applicable, Mfg. Lot/Serial Number 00000443327CN2;  System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN;  System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN;  System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN;  System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN;  System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN;  System ID Number 818708CTWSO, UDI (01)00840682146616(11)220900(21)REV2A2200065CN, Mfg. Lot/Serial Number REV2A2200065CN;  System ID Number 310222REVO, UDI Not Applicable, Mfg. Lot/Serial Number 00000445059CN9;  System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN;  System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN;  System ID Number 203576EDAPEX, UDI (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/Serial Number REV2X2400021CN;  System ID Number 860224EDAPEX, UDI (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/Serial Number REV2X2400050CN;  System ID Number 203276APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/Serial Number REV2X2400095CN;  System ID Number 302744APEX, UDI (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/Serial Number REV2X2400078CN;  System ID Number 561737APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/Serial Number REV2X2400114CN;  System ID Number 561737APEX2, UDI (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/Serial Number REV2X2400112CN;  System ID Number 786243APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/Serial Number REV2X2300059CN;  System ID Number 305323APEX, UDI (01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/Serial Number REV2X2400123CN;  System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN;  System ID Number 863680APEX, UDI (01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/Serial Number REV2X2300057CN;  System ID Number 786596APEX, UDI (01)00195278460271(11)230900(21)REV2X2300068CN, Mfg. Lot/Serial Number REV2X2300068CN;  System ID Number 786596REV, UDI (01)00840682118552(11)180900(21)REVVX1800093CN, Mfg. Lot/Serial Number REVVX1800093CN;  System ID Number 813972APEX, UDI (01)00195278460271(11)230800(21)REV2X2300041CN, Mfg. Lot/Serial Number REV2X2300041CN;  System ID Number 813972APEX2, UDI (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/Serial Number REV2X2400088CN;  System ID Number 813972APEX3, UDI (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/Serial Number REV2X2400135CN;  System ID Number 770219APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400100CN, Mfg. Lot/Serial Number REV2X2400100CN;  System ID Number 478633REVO, UDI (01)00840682118552(11)190200(21)REVVX1900027CN, Mfg. Lot/Serial Number REVVX1900027CN;  System ID Number 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8;  System ID Number 630266CTRV, UDI (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/Serial Number REV2X2400093CN;  System ID Number 773702REVCT6ED, UDI (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/Serial Number REV2X2300071CN;  System ID Number 336884APEX, UDI (01)00195278460271(11)240500(21)REV2X2400064CN, Mfg. Lot/Serial Number REV2X2400064CN. 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-1299-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1299-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1299-2025 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.",
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      "reviewStatus": "current",
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        "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-1299-2025&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-1299-2025&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-1299-2025/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",
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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": "Ongoing — the recall is still being carried out.",
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          "item": {
            "Field": "Recalling firm",
            "Value": "GE Medical Systems, LLC",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.",
            "Status": "recorded"
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            "Field": "Initiated",
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            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN;  System ID Number 205608CT, UDI (01)00840682123471(11)180800(21)REVV81800010CN, Mfg. Lot/Serial Number REVV81800010CN;  System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN;  System ID Number 205699CTREV, UDI Not Applicable, Mfg. Lot/Serial Number 00000442592CN2;  System ID Number 480342APEX, UDI (01)00840682146616(11)220900(21)REV2A2200072CN, Mfg. Lot/Serial Number REV2A2200072CN;  System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN;  System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN;  System ID Number 11320, UDI To be provided, Mfg. Lot/Serial Number REVVX2000033CN;  System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN;  System ID Number 858657APEX, UDI (01)00840682118552(11)160900(21)REVVX1600034CN, Mfg. Lot/Serial Number REVVX1600034CN;  System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN;  System ID Number 858824APEX, UDI Not Applicable, Mfg. Lot/Serial Number 00000443327CN2;  System ID Number 310423CT, UDI (01)00840682118552(11)211200(21)REVVX2100047CN, Mfg. Lot/Serial Number REVVX2100047CN;  System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN;  System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN;  System ID Number 650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN;  System ID Number 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN;  System ID Number 818708CTWSO, UDI (01)00840682146616(11)220900(21)REV2A2200065CN, Mfg. Lot/Serial Number REV2A2200065CN;  System ID Number 310222REVO, UDI Not Applicable, Mfg. Lot/Serial Number 00000445059CN9;  System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN;  System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN;  System ID Number 203576EDAPEX, UDI (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/Serial Number REV2X2400021CN;  System ID Number 860224EDAPEX, UDI (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/Serial Number REV2X2400050CN;  System ID Number 203276APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/Serial Number REV2X2400095CN;  System ID Number 302744APEX, UDI (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/Serial Number REV2X2400078CN;  System ID Number 561737APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/Serial Number REV2X2400114CN;  System ID Number 561737APEX2, UDI (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/Serial Number REV2X2400112CN;  System ID Number 786243APEX1, UDI (01)00195278460271(11)230900(21)REV2X2300059CN, Mfg. Lot/Serial Number REV2X2300059CN;  System ID Number 305323APEX, UDI (01)00195278460271(11)240900(21)REV2X2400123CN, Mfg. Lot/Serial Number REV2X2400123CN;  System ID Number 904UFNAPEX, UDI (01)00195278460271(11)230300(21)REV2X2300001CN, Mfg. Lot/Serial Number REV2X2300001CN;  System ID Number 863680APEX, UDI (01)00195278460271(11)230900(21)REV2X2300057CN, Mfg. Lot/Serial Number REV2X2300057CN;  System ID Number 786596APEX, UDI (01)00195278460271(11)230900(21)REV2X2300068CN, Mfg. Lot/Serial Number REV2X2300068CN;  System ID Number 786596REV, UDI (01)00840682118552(11)180900(21)REVVX1800093CN, Mfg. Lot/Serial Number REVVX1800093CN;  System ID Number 813972APEX, UDI (01)00195278460271(11)230800(21)REV2X2300041CN, Mfg. Lot/Serial Number REV2X2300041CN;  System ID Number 813972APEX2, UDI (01)00195278460271(11)240700(21)REV2X2400088CN, Mfg. Lot/Serial Number REV2X2400088CN;  System ID Number 813972APEX3, UDI (01)00195278460271(11)241000(21)REV2X2400135CN, Mfg. Lot/Serial Number REV2X2400135CN;  System ID Number 770219APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400100CN, Mfg. Lot/Serial Number REV2X2400100CN;  System ID Number 478633REVO, UDI (01)00840682118552(11)190200(21)REVVX1900027CN, Mfg. Lot/Serial Number REVVX1900027CN;  System ID Number 808522RCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441716CN8;  System ID Number 630266CTRV, UDI (01)00195278460271(11)240800(21)REV2X2400093CN, Mfg. Lot/Serial Number REV2X2400093CN;  System ID Number 773702REVCT6ED, UDI (01)00195278460271(11)231000(21)REV2X2300071CN, Mfg. Lot/Serial Number REV2X2300071CN;  System ID Number 336884APEX, UDI (01)00195278460271(11)240500(21)REV2X2400064CN, Mfg. Lot/Serial Number REV2X2400064CN",
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            "Field": "Distribution pattern",
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}