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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2048-2026.jsonld",
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  "name": "LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5",
  "description": "FDA recall Z-2048-2026 — Boston Scientific Corporation is recalling LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 (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": "LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2048-2026/enforcement-record",
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      "name": "FDA recall Z-2048-2026: Boston Scientific Corporation is recalling LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5",
      "text": "The FDA logged enforcement record Z-2048-2026: Boston Scientific Corporation is voluntarily recalling LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 — reason: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-30. Affected lots/codes: LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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-2048-2026/fda-classification",
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      "name": "FDA classified recall Z-2048-2026 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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      "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-2048-2026/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",
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      "epistemicStatus": {
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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": "Boston Scientific Corporation",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.",
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            "Field": "Lot/code info",
            "Value": "LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the country of Belgium.",
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