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  "name": "GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed",
  "description": "FDA recall Z-1297-2025 — GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex, 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 Apex, System, X-ray, Tomography, Computed",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1297-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1297-2025: GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed",
      "text": "The FDA logged enforcement record Z-1297-2025: GE Medical Systems, LLC is voluntarily recalling GE Healthcare Revolution Apex, 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:  650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN;  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:  312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN;  System ID Number:  1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN;  System ID Number:  617726Y6REV2, UDI (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/Serial Number REVVX1700090CN;  System ID Number:  617726Y6REV1, UDI (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/Serial Number REVVX1600018CN;  System ID Number:  336890APEX, UDI (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/Serial Number REV2X2400116CN;  System ID Number:  704801APEX, UDI (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/Serial Number REV2X2400139CN;  System ID Number:  336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN;  System ID Number:  980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN;  System ID Number:  910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Number REV2X2400155CN;  System ID Number:  603650APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/Serial Number REV2X2400068CN;  System ID Number:  603526APEX, UDI (01)00195278469700(11)230100(21)REV242200004CN, Mfg. Lot/Serial Number REV242200004CN;  System ID Number:  973971REV161, UDI (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/Serial Number REV2X2400158CN;  System ID Number:  914787APEX, UDI (01)00195278460271(11)231000(21)REV2X2300081CN, Mfg. Lot/Serial Number REV2X2300081CN;  System ID Number:  718963EDCT, UDI (01)00195278460271(11)240600(21)REV2X2400070CN, Mfg. 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Lot/Serial Number REV2X2400055CN;  System ID Number:  832CT000059, UDI (01)00840682146616(11)220100(21)REV2A2200006CN, Mfg. Lot/Serial Number REV2A2200006CN;  System ID Number:  833CT000155, UDI (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/Serial Number REV2X2400053CN;  System ID Number:  AH7084CT02, UDI (01)00840682146616(11)220100(21)REV2A2200007CN, Mfg. Lot/Serial Number REV2A2200007CN;  System ID Number:  AH1923CT01, UDI (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/Serial Number REV2X2400024CN;  System ID Number:  BG4549CT04, UDI (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/Serial Number REV2X2300026CN;  System ID Number:  E416249APEXCTE, UDI (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/Serial Number REV2X2300087CN;  System ID Number:  082421140968, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number:  082421140960, UDI (01)00195278633149(11)240500(21)CBFCG2400006HM, Mfg. Lot/Serial Number CBFCG2400006HM;  System ID Number:  082421140959, UDI (01)00195278633149(11)240500(21)CBFCG2400004HM, Mfg. Lot/Serial Number CBFCG2400004HM;  System ID Number:  DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN;  System ID Number:  DK1547CT01, UDI (01)00840682123471(11)210100(21)REVV82100002CN, Mfg. Lot/Serial Number REVV82100002CN;  System ID Number:  DK1051CT04, UDI To be provided, Mfg. Lot/Serial Number 00000442412CN3;  System ID Number:  CT52261701, UDI To be provided, Mfg. Lot/Serial Number REV2X2300050CN;  System ID Number:  M40230104, UDI (01)00840682118552(11)160600(21)REVVX1600012CN, Mfg. Lot/Serial Number REVVX1600012CN;  System ID Number:  REV020, UDI To be provided, Mfg. Lot/Serial Number 00000442334CN9;  System ID Number:  CT00486, UDI (01)00195278460271(11)231000(21)REV2X2300079CN, Mfg. Lot/Serial Number REV2X2300079CN;  System ID Number:  KRCT54972221, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number:  KRCT54893311, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number:  0850211084, UDI To be provided, Mfg. Lot/Serial Number REV2X2300016CN;  System ID Number:  NO1068CT04, UDI (01)00840682118552(11)171000(21)REVVX1700106CN, Mfg. Lot/Serial Number REVVX1700106CN;  System ID Number:  P00652CT01, UDI (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/Serial Number REV2X2400017CN;  System ID Number:  PL1672CT03, UDI (01)00840682146616(11)210600(21)REV2A2100019CN, Mfg. Lot/Serial Number REV2A2100019CN;  System ID Number:  SA1420CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X2400137CN;  System ID Number:  SA2973CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X23000030CN;  System ID Number:  CT53972381, UDI To be provided, Mfg. Lot/Serial Number REV2X2400121CN;  System ID Number:  A201CT07, UDI (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/Serial Number REV2X2400014CN;  System ID Number:  AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN;  System ID Number:  541010CT02, UDI (01)00840682118552(11)190900(21)REVVX1900106CN, Mfg. Lot/Serial Number REVVX1900106CN;  System ID Number:  THCTX24524601, UDI (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/Serial Number REV2X2400131CN;  System ID Number:  AE1025CT03, UDI (01)00840682118552(11)210300(21)REVVX2100010CN, Mfg. Lot/Serial Number REVVX2100010CN.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
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        "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-1297-2025&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-1297-2025&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-1297-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1297-2025 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-1297-2025&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-1297-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1297-2025/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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        "supported": true,
        "adjudged": false,
        "operative": true
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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."
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      "name": "FDA recall details — Z-1297-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1297-2025",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "GE Medical Systems, LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-02-18",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Lot/code info",
            "Value": "System ID Number:  907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN;  System ID Number:  650493REV1, UDI To be provided, Mfg. Lot/Serial Number REVVX1900035CN;  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:  312996CTRV2, UDI (01)00195278460271(11)241000(21)REV2X2400126CN, Mfg. Lot/Serial Number REV2X2400126CN;  System ID Number:  1000000018, UDI To be provided, Mfg. Lot/Serial Number REV2X2300074CN;  System ID Number:  617726Y6REV2, UDI (01)00840682118552(11)170900(21)REVVX1700090CN, Mfg. Lot/Serial Number REVVX1700090CN;  System ID Number:  617726Y6REV1, UDI (01)00840682118552(11)160700(21)REVVX1600018CN, Mfg. Lot/Serial Number REVVX1600018CN;  System ID Number:  336890APEX, UDI (01)00195278460271(11)240900(21)REV2X2400116CN, Mfg. Lot/Serial Number REV2X2400116CN;  System ID Number:  704801APEX, UDI (01)00195278460271(11)241000(21)REV2X2400139CN, Mfg. Lot/Serial Number REV2X2400139CN;  System ID Number:  336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN;  System ID Number:  980993CT1, UDI (01)00840682146616(11)210700(21)REV2A2100029CN, Mfg. Lot/Serial Number REV2A2100029CN;  System ID Number:  910715REV1, UDI (01)00195278460271(11)241200(21)REV2X2400155CN, Mfg. Lot/Serial Number REV2X2400155CN;  System ID Number:  603650APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400068CN, Mfg. Lot/Serial Number REV2X2400068CN;  System ID Number:  603526APEX, UDI (01)00195278469700(11)230100(21)REV242200004CN, Mfg. Lot/Serial Number REV242200004CN;  System ID Number:  973971REV161, UDI (01)00195278460271(11)241200(21)REV2X2400158CN, Mfg. Lot/Serial Number REV2X2400158CN;  System ID Number:  914787APEX, UDI (01)00195278460271(11)231000(21)REV2X2300081CN, Mfg. Lot/Serial Number REV2X2300081CN;  System ID Number:  718963EDCT, UDI (01)00195278460271(11)240600(21)REV2X2400070CN, Mfg. Lot/Serial Number REV2X2400070CN;  System ID Number:  315473APEX1, UDI (01)00195278460271(11)241100(21)REV2X2400152CN, Mfg. Lot/Serial Number REV2X2400152CN;  System ID Number:  614RMHAPEX1, UDI (01)00195278460271(11)240300(21)REV2X2400026CN, Mfg. Lot/Serial Number REV2X2400026CN;  System ID Number:  724357APEX, UDI (01)00195278460271(11)230800(21)REV2X2300046CN, Mfg. Lot/Serial Number REV2X2300046CN;  System ID Number:  843797REVCT2, UDI (01)00840682123471(11)211100(21)REVV82100041CN, Mfg. Lot/Serial Number REVV82100041CN;  System ID Number:  806775APEX, UDI (01)00195278460271(11)231000(21)REV2X2300075CN, Mfg. Lot/Serial Number REV2X2300075CN;  System ID Number:  703776APEX, UDI To be provided, Mfg. Lot/Serial Number REV2X2400167CN;  System ID Number:  414805REVCT, UDI Not Applicable, Mfg. Lot/Serial Number 00000441066CN8;  System ID Number:  262577REVCT, UDI (01)00195278460271(11)240500(21)REV2X2400055CN, Mfg. Lot/Serial Number REV2X2400055CN;  System ID Number:  832CT000059, UDI (01)00840682146616(11)220100(21)REV2A2200006CN, Mfg. Lot/Serial Number REV2A2200006CN;  System ID Number:  833CT000155, UDI (01)00195278460271(11)240500(21)REV2X2400053CN, Mfg. Lot/Serial Number REV2X2400053CN;  System ID Number:  AH7084CT02, UDI (01)00840682146616(11)220100(21)REV2A2200007CN, Mfg. Lot/Serial Number REV2A2200007CN;  System ID Number:  AH1923CT01, UDI (01)00195278460271(11)240300(21)REV2X2400024CN, Mfg. Lot/Serial Number REV2X2400024CN;  System ID Number:  BG4549CT04, UDI (01)00195278460271(11)230600(21)REV2X2300026CN, Mfg. Lot/Serial Number REV2X2300026CN;  System ID Number:  E416249APEXCTE, UDI (01)00195278460271(11)231100(21)REV2X2300087CN, Mfg. Lot/Serial Number REV2X2300087CN;  System ID Number:  082421140968, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number:  082421140960, UDI (01)00195278633149(11)240500(21)CBFCG2400006HM, Mfg. Lot/Serial Number CBFCG2400006HM;  System ID Number:  082421140959, UDI (01)00195278633149(11)240500(21)CBFCG2400004HM, Mfg. Lot/Serial Number CBFCG2400004HM;  System ID Number:  DK1044CT12, UDI (01)00840682146616(11)200200(21)REV2A2000001CN, Mfg. Lot/Serial Number REV2A2000001CN;  System ID Number:  DK1547CT01, UDI (01)00840682123471(11)210100(21)REVV82100002CN, Mfg. Lot/Serial Number REVV82100002CN;  System ID Number:  DK1051CT04, UDI To be provided, Mfg. Lot/Serial Number 00000442412CN3;  System ID Number:  CT52261701, UDI To be provided, Mfg. Lot/Serial Number REV2X2300050CN;  System ID Number:  M40230104, UDI (01)00840682118552(11)160600(21)REVVX1600012CN, Mfg. Lot/Serial Number REVVX1600012CN;  System ID Number:  REV020, UDI To be provided, Mfg. Lot/Serial Number 00000442334CN9;  System ID Number:  CT00486, UDI (01)00195278460271(11)231000(21)REV2X2300079CN, Mfg. Lot/Serial Number REV2X2300079CN;  System ID Number:  KRCT54972221, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number:  KRCT54893311, UDI To be provided, Mfg. Lot/Serial Number Not Available;  System ID Number:  0850211084, UDI To be provided, Mfg. Lot/Serial Number REV2X2300016CN;  System ID Number:  NO1068CT04, UDI (01)00840682118552(11)171000(21)REVVX1700106CN, Mfg. Lot/Serial Number REVVX1700106CN;  System ID Number:  P00652CT01, UDI (01)00195278460271(11)240200(21)REV2X2400017CN, Mfg. Lot/Serial Number REV2X2400017CN;  System ID Number:  PL1672CT03, UDI (01)00840682146616(11)210600(21)REV2A2100019CN, Mfg. Lot/Serial Number REV2A2100019CN;  System ID Number:  SA1420CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X2400137CN;  System ID Number:  SA2973CT01, UDI To be provided, Mfg. Lot/Serial Number REV2X23000030CN;  System ID Number:  CT53972381, UDI To be provided, Mfg. Lot/Serial Number REV2X2400121CN;  System ID Number:  A201CT07, UDI (01)00195278460271(11)240200(21)REV2X2400014CN, Mfg. Lot/Serial Number REV2X2400014CN;  System ID Number:  AC001CT05, UDI (01)00840682118552(11)181000(21)REVVX1800101CN, Mfg. Lot/Serial Number REVVX1800101CN;  System ID Number:  541010CT02, UDI (01)00840682118552(11)190900(21)REVVX1900106CN, Mfg. Lot/Serial Number REVVX1900106CN;  System ID Number:  THCTX24524601, UDI (01)00195278460271(11)241000(21)REV2X2400131CN, Mfg. Lot/Serial Number REV2X2400131CN;  System ID Number:  AE1025CT03, UDI (01)00840682118552(11)210300(21)REVVX2100010CN, Mfg. Lot/Serial Number REVVX2100010CN.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}