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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0684-2025.jsonld",
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  "name": "Eclipse PRO REF 98700    The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.",
  "description": "FDA recall Z-0684-2025 — Spacelabs Healthcare, Ltd. is recalling Eclipse PRO REF 98700    The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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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-0684-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Eclipse PRO REF 98700    The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.",
    "manufacturer": {
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      "name": "Spacelabs Healthcare, Ltd."
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      "name": "FDA recall Z-0684-2025: Spacelabs Healthcare, Ltd. is recalling Eclipse PRO REF 98700    The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.",
      "text": "The FDA logged enforcement record Z-0684-2025: Spacelabs Healthcare, Ltd. is voluntarily recalling Eclipse PRO REF 98700    The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. — reason: Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder.  The physical serial number label on the device might not match the serial number programmed into the device.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-25. Affected lots/codes: Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers:  All serial numbers manufactured between April 2021 to November 2024.  Serial Numbers pending.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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      "epistemicStatus": {
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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-0684-2025&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-0684-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0684-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0684-2025 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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        "value": "Class II",
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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-0684-2025/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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        "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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      "name": "FDA recall details — Z-0684-2025",
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            "Value": "Z-0684-2025",
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            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Value": "Spacelabs Healthcare, Ltd.",
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          "item": {
            "Field": "Reason",
            "Value": "Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder.  The physical serial number label on the device might not match the serial number programmed into the device.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-11-25",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers:  All serial numbers manufactured between April 2021 to November 2024.  Serial Numbers pending.",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI.  O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain Belgium El Salvador Martinique Sweden Benin France Mexico Switzerland Bolivia Germany Netherlands Taiwan Brazil Greece Oman Trinidad and Tobago Brunei Darussalam Guatemala Panama Turkey Canada Honduras Peru United Arab Emirates Chile Hong Kong Poland United Kingdom China Iceland Portugal Columbia India Venezuela Congo Ireland Qatar Viet Nam Costa Rica Israel Republic of Macedonia Croatia Italy Roumanie Czech Republic Korea, Republic of Saudi Arabia",
            "Status": "recorded"
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