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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1590-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP",
  "description": "FDA recall Z-1590-2026 — GE Medical Systems, LLC is recalling Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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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-1590-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "GE Medical Systems, LLC"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1590-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1590-2026: GE Medical Systems, LLC is recalling Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP",
      "text": "The FDA logged enforcement record Z-1590-2026: GE Medical Systems, LLC is voluntarily recalling Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP — reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-03. Affected lots/codes: HIBC: +B681J02000; E85101LA: IMB-22-013 IMB-24-013 IMB-23-006 IMB-24-001 IMB-24-016 IMB-24-018 IMB-24-007 IMB-21-001 IMB-23-004 IMB-24-015 IMB-22-014 IMB-22-011 IMB-21-008 IMB-22-010 IMB-23-003 IMB-22-002 IMB-16-005 IMB-16-002 IMB-17-007 IMB-21-003 IMB-16-003 IMB-18-006 IMB-16-006 IMB-19-014 IMB-23-007 IMB-19-011 IMB-24-011 IMB-15-001 IMB-24-009 IMB-20-005 IMB-19-009 IMB-15-003 IMB-18-007 IMB-17-011 IMB-18-003 IMB-19-003 IMB-17-006 IMB-20-004 IMB-21-005 IMB-21-006 IMB-20-012 IMB-22-004 IMB-17-008 IMB-20-022 IMB-19-019 IMB-18-004 IMB-17-012 IMB-19-008 IMB-15-004 IMB-16-004 IMB-17-005 IMB-18-002 IMB-18-005 IMB-18-010 IMB-19-005 IMB-15-002 IMB-17-009 IMB-17-010 IMB-24-012 IMB-17-002 IMB-20-016 IMB-22-007 IMB-24-002 IMB-20-010 IMB-22-005 IMB-22-017 IMB-24-021 IMB-19-002 IMB-24-017 IMB-20-021 IMB-19-007 IMB-24-014 IMB-24-004 IMB-24-020 IMB-19-013 IMB-20-009 IMB-24-006 IMB-20-008 IMB-24-023 IMB-24-022 IMB-18-009 IMB-19-001 IMB-19-004 IMB-19-006 IMB-19-010 IMB-19-016 IMB-22-001 IMB-22-012 IMB-22-016 IMB-22-018 IMB-17-003 IMB-24-005 IMB-16-007 IMB-22-015 IMB-24-003 IMB-20-002 IMB-20-003 IMB-20-017 IMB-20-018 IMB-20-019 IMB-21-002 IMB-21-004 IMB-22-003 IMB-22-008 IMB-22-009 IMB-20-011 IMB-20-020; E85101LP:  IMB-25-005 IMB-21-007 IMB-25-007 IMB-25-008 IMB-20-001 IMB-20-013 IMB-25-012 IMB-25-009 IMB-25-006 IMB-21-009 IMB-25-013 IMB-25-010 IMB-19-012 IMB-25-001 IMB-25-004 IMB-24-024 IMB-25-023 IMB-25-003. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "occurred": true,
        "supported": true,
        "adjudged": 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-1590-2026&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-1590-2026&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-1590-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1590-2026 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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        "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-1590-2026&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-1590-2026&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-1590-2026/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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1590-2026",
      "numberOfItems": 9,
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            "Value": "Z-1590-2026",
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            "Value": "Class II",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "GE Medical Systems, LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-03",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "HIBC: +B681J02000; E85101LA: IMB-22-013 IMB-24-013 IMB-23-006 IMB-24-001 IMB-24-016 IMB-24-018 IMB-24-007 IMB-21-001 IMB-23-004 IMB-24-015 IMB-22-014 IMB-22-011 IMB-21-008 IMB-22-010 IMB-23-003 IMB-22-002 IMB-16-005 IMB-16-002 IMB-17-007 IMB-21-003 IMB-16-003 IMB-18-006 IMB-16-006 IMB-19-014 IMB-23-007 IMB-19-011 IMB-24-011 IMB-15-001 IMB-24-009 IMB-20-005 IMB-19-009 IMB-15-003 IMB-18-007 IMB-17-011 IMB-18-003 IMB-19-003 IMB-17-006 IMB-20-004 IMB-21-005 IMB-21-006 IMB-20-012 IMB-22-004 IMB-17-008 IMB-20-022 IMB-19-019 IMB-18-004 IMB-17-012 IMB-19-008 IMB-15-004 IMB-16-004 IMB-17-005 IMB-18-002 IMB-18-005 IMB-18-010 IMB-19-005 IMB-15-002 IMB-17-009 IMB-17-010 IMB-24-012 IMB-17-002 IMB-20-016 IMB-22-007 IMB-24-002 IMB-20-010 IMB-22-005 IMB-22-017 IMB-24-021 IMB-19-002 IMB-24-017 IMB-20-021 IMB-19-007 IMB-24-014 IMB-24-004 IMB-24-020 IMB-19-013 IMB-20-009 IMB-24-006 IMB-20-008 IMB-24-023 IMB-24-022 IMB-18-009 IMB-19-001 IMB-19-004 IMB-19-006 IMB-19-010 IMB-19-016 IMB-22-001 IMB-22-012 IMB-22-016 IMB-22-018 IMB-17-003 IMB-24-005 IMB-16-007 IMB-22-015 IMB-24-003 IMB-20-002 IMB-20-003 IMB-20-017 IMB-20-018 IMB-20-019 IMB-21-002 IMB-21-004 IMB-22-003 IMB-22-008 IMB-22-009 IMB-20-011 IMB-20-020; E85101LP:  IMB-25-005 IMB-21-007 IMB-25-007 IMB-25-008 IMB-20-001 IMB-20-013 IMB-25-012 IMB-25-009 IMB-25-006 IMB-21-009 IMB-25-013 IMB-25-010 IMB-19-012 IMB-25-001 IMB-25-004 IMB-24-024 IMB-25-023 IMB-25-003",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}