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  "name": "GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system",
  "description": "FDA recall Z-0605-2025 — GE Healthcare (China) Co., Ltd. is recalling GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system (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": "GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system",
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      "name": "GE Healthcare (China) Co., Ltd."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0605-2025/enforcement-record",
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      "name": "FDA recall Z-0605-2025: GE Healthcare (China) Co., Ltd. is recalling GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system",
      "text": "The FDA logged enforcement record Z-0605-2025: GE Healthcare (China) Co., Ltd. is voluntarily recalling GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system — reason: GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-05. Affected lots/codes: UDI/DI 00840682146173, Serial/Sales Order Numbers:  CBDWG2400109HM, CBDWG2400103HM, CBDWG2400102HM, CBDWG2400096HM, CBDWG2400111HM, CBDWG2400106HM, CBDWG2400115HM, CBDWG2400113HM, CBDWG2400105HM, CBDWG2400112HM, CBDWG2400116HM, CBDWG2400114HM, CBDWG2400107HM, CBDWG2400104HM, CBDWG2400110HM, CBDWG2400108HM. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0605-2025&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-0605-2025&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-0605-2025/fda-classification",
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      "name": "FDA classified recall Z-0605-2025 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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0605-2025/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.",
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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
      },
      "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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            "Field": "Recalling firm",
            "Value": "GE Healthcare (China) Co., Ltd.",
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          "item": {
            "Field": "Reason",
            "Value": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.",
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            "Field": "Initiated",
            "Value": "2024-11-05",
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            "Value": "UDI/DI 00840682146173, Serial/Sales Order Numbers:  CBDWG2400109HM, CBDWG2400103HM, CBDWG2400102HM, CBDWG2400096HM, CBDWG2400111HM, CBDWG2400106HM, CBDWG2400115HM, CBDWG2400113HM, CBDWG2400105HM, CBDWG2400112HM, CBDWG2400116HM, CBDWG2400114HM, CBDWG2400107HM, CBDWG2400104HM, CBDWG2400110HM, CBDWG2400108HM",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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