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  "name": "Colonoscope, Model Number CF-HQ190L.",
  "description": "FDA recall Z-1207-2024 — Olympus Corporation of the Americas is recalling Colonoscope, Model Number CF-HQ190L. (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": "FDA recall Z-1207-2024: Olympus Corporation of the Americas is recalling Colonoscope, Model Number CF-HQ190L.",
      "text": "The FDA logged enforcement record Z-1207-2024: Olympus Corporation of the Americas is voluntarily recalling Colonoscope, Model Number CF-HQ190L. — reason: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-11. Affected lots/codes: Model Number: CF-HQ190L; UDI DI: 04953170305115;  Serial Number: 2082724, 2082896, 2082936, 2083461, 2083765, 2084560, 2085050, 2186261, 2187110, 2187274, 2187811, 2188037, 2188206, 2200530, 2201625, 2201677, 2201844, 2202345, 2288483, 2288940, 2289129, 2289391, 2289421, 2289572, 2290978, 2291472, 2303312, 2304024, 2304070, 2314598, 2315390, 2391750, 2391772, 2391857, 2392281, 2417328, 2417450, 2417702, 2417736, 2417755, 2418202, 2418754, 2418843, 2419006, 2419007, 2419105, 2510489, 2510795, 2510801, 2511164, 2512292, 2512458, 2512470, 2512569, 2512817, 2513285, 2524619, 2524916, 2625144, 2635605, 2635832, 2636020, 2636500, 2636782, 2637892, 2659060, 2659357, 2759754, 2761671, 2762243, 2772492, 2773247, 2773259, 2773324, 2773552, 2874236, 2875490, 2875615, 2875616, 2875656, 2876636, 2876811, 2876877, 2877237, 2877319, 2877901, 2978291, 2978331, 2978640, 2979287, 2979510, 2980281, 2980304, 2980541, 2981322, 2982038, 2982143;. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
        "operative": 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-1207-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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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      "name": "FDA classified recall Z-1207-2024 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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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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-1207-2024/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": "Reason",
            "Value": "Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-01-11",
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            "Value": "Model Number: CF-HQ190L; UDI DI: 04953170305115;  Serial Number: 2082724, 2082896, 2082936, 2083461, 2083765, 2084560, 2085050, 2186261, 2187110, 2187274, 2187811, 2188037, 2188206, 2200530, 2201625, 2201677, 2201844, 2202345, 2288483, 2288940, 2289129, 2289391, 2289421, 2289572, 2290978, 2291472, 2303312, 2304024, 2304070, 2314598, 2315390, 2391750, 2391772, 2391857, 2392281, 2417328, 2417450, 2417702, 2417736, 2417755, 2418202, 2418754, 2418843, 2419006, 2419007, 2419105, 2510489, 2510795, 2510801, 2511164, 2512292, 2512458, 2512470, 2512569, 2512817, 2513285, 2524619, 2524916, 2625144, 2635605, 2635832, 2636020, 2636500, 2636782, 2637892, 2659060, 2659357, 2759754, 2761671, 2762243, 2772492, 2773247, 2773259, 2773324, 2773552, 2874236, 2875490, 2875615, 2875616, 2875656, 2876636, 2876811, 2876877, 2877237, 2877319, 2877901, 2978291, 2978331, 2978640, 2979287, 2979510, 2980281, 2980304, 2980541, 2981322, 2982038, 2982143;",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
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