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  "name": "GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:    1) ASM000085;   2) ASM001092;   3) SYS000001; System, Tomography, Computed, Emission",
  "description": "FDA recall Z-0900-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:    1) ASM000085;   2) ASM001092;   3) SYS000001; System, Tomography, Computed, Emission (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0900-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:    1) ASM000085;   2) ASM001092;   3) SYS000001; System, Tomography, Computed, Emission",
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      "name": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0900-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0900-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:    1) ASM000085;   2) ASM001092;   3) SYS000001; System, Tomography, Computed, Emission",
      "text": "The FDA logged enforcement record Z-0900-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:    1) ASM000085;   2) ASM001092;   3) SYS000001; System, Tomography, Computed, Emission — reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-18. Affected lots/codes: 1) ASM000085:  UDI/DI N/A, System ID NM10569, Serial Number 10569; UDI/DI N/A, System ID NM10570, Serial Number 10570; UDI/DI N/A, System ID YN0845, Serial Number 10242; UDI/DI N/A, System ID YN0498, Serial Number 1092; UDI/DI N/A, System ID YN0440, Serial Number 1003; UDI/DI N/A,  System ID 979764VGH1, Serial Number 77521848; UDI/DI N/A, System ID NM10225, Serial Number 10225.         2) ASM001092:  UDI/DI N/A, System ID 310231VGH1, Serial Number 10539; UDI/DI N/A, System ID 207795VH, Serial Number 10571; UDI/DI N/A, System ID 82426070015, Serial Number 10550; UDI/DI N/A, System ID 82426210010, Serial Number 10595; UDI/DI N/A, System ID 82426280001, Serial Number 10591; UDI/DI N/A, System ID 082426080009, Serial Number 10599; UDI/DI N/A, System ID H2103NUC06, Serial Number 10582; UDI/DI N/A, System ID H1404NUC06, Serial Number 10604; UDI/DI N/A, System ID H2094NUC07, Serial Number 10587; UDI/DI N/A, System ID YN0984, Serial Number 10543; UDI/DI N/A, System ID 850260054, Serial Number 10579; UDI/DI N/A, System ID RU1591NM01, Serial Number 10561; UDI/DI N/A, System ID RU1457NM01, Serial Number 10553; UDI/DI N/A,  System ID 209526MILVG, Serial Number 10340; UDI/DI N/A,  System ID 416469DVH, Serial Number 10384; UDI/DI N/A,  System ID CY1088MN04, Serial Number 10360; UDI/DI N/A,  System ID Not Available, Serial Number 81251648; UDI/DI N/A,  System ID B5315325, Serial Number 10185.    3) ASM001099:  UDI/DI N/A, System ID PER10925, Serial Number 10346.    4) SYS000001:  UDI/DI N/A, System ID NM10374, Serial Number 10374; UDI/DI N/A, System ID NM10147, Serial Number 10147; UDI/DI N/A, System ID 334794MILVG, Serial Number 1063;  UDI/DI N/A, System ID NM10291, Serial number 10291;  UDI/DI N/A, System ID 56948, Serial number 1021.       5) SYS000002:  UDI/DI N/A, System ID 949760VG1, Serial Number 10445; UDI/DI N/A, System ID NM10174, Serial Number 10174;   UDI/DI N/A, System ID 223410MILVG, Serial Number 1069.    6) SYS000003:  UDI/DI N/A, System ID 914734VG, Serial number 10435.. A RECORDED FDA enforcement action (occurred=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-0900-2025&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-0900-2025&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-0900-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0900-2025 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",
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        "supported": true,
        "adjudged": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-0900-2025&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-0900-2025/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
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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-0900-2025",
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            "Value": "Z-0900-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "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 ISRAEL, FUNCTIONAL IMAGING",
            "Status": "recorded"
          }
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Initiated",
            "Value": "2024-12-18",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) ASM000085:  UDI/DI N/A, System ID NM10569, Serial Number 10569; UDI/DI N/A, System ID NM10570, Serial Number 10570; UDI/DI N/A, System ID YN0845, Serial Number 10242; UDI/DI N/A, System ID YN0498, Serial Number 1092; UDI/DI N/A, System ID YN0440, Serial Number 1003; UDI/DI N/A,  System ID 979764VGH1, Serial Number 77521848; UDI/DI N/A, System ID NM10225, Serial Number 10225.         2) ASM001092:  UDI/DI N/A, System ID 310231VGH1, Serial Number 10539; UDI/DI N/A, System ID 207795VH, Serial Number 10571; UDI/DI N/A, System ID 82426070015, Serial Number 10550; UDI/DI N/A, System ID 82426210010, Serial Number 10595; UDI/DI N/A, System ID 82426280001, Serial Number 10591; UDI/DI N/A, System ID 082426080009, Serial Number 10599; UDI/DI N/A, System ID H2103NUC06, Serial Number 10582; UDI/DI N/A, System ID H1404NUC06, Serial Number 10604; UDI/DI N/A, System ID H2094NUC07, Serial Number 10587; UDI/DI N/A, System ID YN0984, Serial Number 10543; UDI/DI N/A, System ID 850260054, Serial Number 10579; UDI/DI N/A, System ID RU1591NM01, Serial Number 10561; UDI/DI N/A, System ID RU1457NM01, Serial Number 10553; UDI/DI N/A,  System ID 209526MILVG, Serial Number 10340; UDI/DI N/A,  System ID 416469DVH, Serial Number 10384; UDI/DI N/A,  System ID CY1088MN04, Serial Number 10360; UDI/DI N/A,  System ID Not Available, Serial Number 81251648; UDI/DI N/A,  System ID B5315325, Serial Number 10185.    3) ASM001099:  UDI/DI N/A, System ID PER10925, Serial Number 10346.    4) SYS000001:  UDI/DI N/A, System ID NM10374, Serial Number 10374; UDI/DI N/A, System ID NM10147, Serial Number 10147; UDI/DI N/A, System ID 334794MILVG, Serial Number 1063;  UDI/DI N/A, System ID NM10291, Serial number 10291;  UDI/DI N/A, System ID 56948, Serial number 1021.       5) SYS000002:  UDI/DI N/A, System ID 949760VG1, Serial Number 10445; UDI/DI N/A, System ID NM10174, Serial Number 10174;   UDI/DI N/A, System ID 223410MILVG, Serial Number 1069.    6) SYS000003:  UDI/DI N/A, System ID 914734VG, Serial number 10435.",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide",
            "Status": "recorded"
          }
        }
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  ]
}