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  "name": "Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and  surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.",
  "description": "FDA recall Z-1581-2025 — Philips North America Llc is recalling Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and  surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices. (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1581-2025&lang=eng",
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    "name": "Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and  surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.",
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      "name": "Philips North America Llc"
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      "name": "FDA recall Z-1581-2025: Philips North America Llc is recalling Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and  surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.",
      "text": "The FDA logged enforcement record Z-1581-2025: Philips North America Llc is recalling (FDA-mandated) Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and  surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices. — reason: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal,  resulting in the emission of unintended radiation.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-25. Affected lots/codes: Product UDI: (01)00884838091528(21). 459801442981, Wireless foot switch set 3P (WFSS 3P) 459801238231, Wireless foot switch 3P, 459801257861, WFS Base Station 459800627394, Wireless foot switch set 3P 459800415535, Wireless foot switch 3P, 459800415542, WFS Base Station. A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": 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-1581-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-1581-2025&lang=eng"
        }
      },
      "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-1581-2025/fda-classification",
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      "name": "FDA classified recall Z-1581-2025 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",
        "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-1581-2025/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,
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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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          "item": {
            "Field": "Reason",
            "Value": "A wireless foot switch pedal may get stuck in the active position when the user releases the pedal,  resulting in the emission of unintended radiation.",
            "Status": "recorded"
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            "Field": "Initiated",
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