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  "name": "LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.",
  "description": "FDA recall Z-1216-2023 — Boston Scientific Corporation is recalling LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460. (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": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1216-2023&lang=eng",
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    "name": "LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.",
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      "name": "FDA recall Z-1216-2023: Boston Scientific Corporation is recalling LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.",
      "text": "The FDA logged enforcement record Z-1216-2023: Boston Scientific Corporation is voluntarily recalling LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460. — reason: Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022.  For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider... Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-02. Affected lots/codes: UDI-DI: 00802526613876. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1216-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1216-2023&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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      "name": "FDA classified recall Z-1216-2023 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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      "epistemicStatus": {
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        "adjudged": true,
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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."
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      "@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": {
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        "supported": true,
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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": "Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022.  For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..",
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            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI.",
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