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  "name": "Ingenia 1.5T S  Model Number (REF):   781347",
  "description": "FDA recall Z-1847-2024 — Philips North America Llc is recalling Ingenia 1.5T S  Model Number (REF):   781347 (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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      "name": "FDA recall Z-1847-2024: Philips North America Llc is recalling Ingenia 1.5T S  Model Number (REF):   781347",
      "text": "The FDA logged enforcement record Z-1847-2024: Philips North America Llc is voluntarily recalling Ingenia 1.5T S  Model Number (REF):   781347 — reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-03. Affected lots/codes: UDI-DI:  (01)00884838068421(21)  Serial Numbers:  81003 81050 81051 81090 81111 81010 81027 81028 81030 81035 81063 81106 81093 81105 81116 81007 81004 81006 81009 81011 81016 81017 81018 81019 81020 81023 81024 81031 81037 81041 81055 81056 81057 81060 81062 81064 81070 81074 81078 81112 81115 81122 81146 81147 81153 81156 81158 81013 81044 81040 81047 81059 81167 81170 81171 81008 81108 81148 81133 81164 81001 81086 81079 81118 81138 81139 81140 81151 81175 81184 81069 81061 81065 81098 81085 81091 81092 81032 81043 81129 81131 81149 81155 81162 81165 81172 81180 81084 81087 81088 81094 81095 81100 81127 81132 81174 81157 81176 81071 81052 81067 81039 81038 81179 81185 81117 81173 81154 81025 81097 81152 81015 81029 81033 81034 81042 81046 81048 81049 81058 81072 81080 81103 81113 81123 81128 81137 81045 81075 81076 81077 81096 81114 81124 81126 81145 81159 81178. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-1847-2024 as 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."
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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.",
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      "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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