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  "name": "Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23",
  "description": "FDA recall Z-2151-2026 — GE Medical Systems, LLC is recalling Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 (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": "Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23",
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      "name": "FDA recall Z-2151-2026: GE Medical Systems, LLC is recalling Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23",
      "text": "The FDA logged enforcement record Z-2151-2026: GE Medical Systems, LLC is voluntarily recalling Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 — reason: GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-26. Affected lots/codes: UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
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        "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-2151-2026&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-2151-2026/fda-classification",
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      "name": "FDA classified recall Z-2151-2026 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.",
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        }
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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-2151-2026/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.",
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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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            "Value": "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2026-03-26",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution.",
            "Status": "recorded"
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