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  "name": "GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed",
  "description": "FDA recall Z-1303-2025 — GE Medical Systems, LLC is recalling GE Healthcare Revolution CT ES, 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": "GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1303-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1303-2025: GE Medical Systems, LLC is recalling GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed",
      "text": "The FDA logged enforcement record Z-1303-2025: GE Medical Systems, LLC is voluntarily recalling GE Healthcare Revolution CT ES, 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 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN;  System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN;  System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN;  System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN;  System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN;  System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5;  System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN;  System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM;  System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN;  System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN;  System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN;  System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN;  System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM;  System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN;  System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN;  System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN;  System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN;  System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN;  System ID Number AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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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      "name": "FDA classified recall Z-1303-2025 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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      "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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      "@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.",
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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
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      "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.",
            "Status": "recorded"
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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",
            "Value": "2025-02-18",
            "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 650493REV2, UDI To be provided, Mfg. Lot/Serial Number REVVX1900036CN;  System ID Number 864512APEX1, UDI (01)00195278460271(11)240500(21)REV2X2400059CN, Mfg. Lot/Serial Number REV2X2400059CN;  System ID Number 832325REV, UDI (01)00195278460271(11)241000(21)REV2X2400134CN, Mfg. Lot/Serial Number REV2X2400134CN;  System ID Number 281MWREVCT, UDI To be provided, Mfg. Lot/Serial Number REVVX1900008CN;  System ID Number 713792ACT39, UDI To be provided, Mfg. Lot/Serial Number REVV82100006CN;  System ID Number 206320REV, UDI To be provided, Mfg. Lot/Serial Number 00000441459CN5;  System ID Number 206320REV2, UDI To be provided, Mfg. Lot/Serial Number REVV82200025CN;  System ID Number 082421190701, UDI (01)00195278633149(11)241100(21)CBFCG2400026HM, Mfg. Lot/Serial Number CBFCG2400026HM;  System ID Number DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN;  System ID Number DK1547CT02, UDI (01)00840682146616(11)210100(21)REV2A2100002CN, Mfg. Lot/Serial Number REV2A2100002CN;  System ID Number 11525316, UDI To be provided, Mfg. Lot/Serial Number REV2X2400082CN;  System ID Number 259056CT01, UDI (01)00195278460271(11)230800(21)REV2X2300051CN, Mfg. Lot/Serial Number REV2X2300051CN;  System ID Number 11437190, UDI To be provided, Mfg. Lot/Serial Number CBGLG2400001HM;  System ID Number 0850211094, UDI (01)00195278460271(11)230800(21)REV2X2300048CN, Mfg. Lot/Serial Number REV2X2300048CN;  System ID Number 12622329, UDI To be provided, Mfg. Lot/Serial Number REV2X2400165CN;  System ID Number M001CT06, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number M004CT02, UDI (01)00195278460271(11)230400(21)REV2X2300005CN, Mfg. Lot/Serial Number REV2X2300005CN;  System ID Number AC002CT05, UDI (01)00840682123471(11)190100(21)REVV81900003CN, Mfg. Lot/Serial Number REVV81900003CN;  System ID Number R002CT12, UDI (01)00195278460271(11)230500(21)REV2X2300012CN, Mfg. Lot/Serial Number REV2X2300012CN;  System ID Number AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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