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  "name": "Bubble Sensor (REF: 70105.5720)",
  "description": "FDA recall Z-1053-2024 — Maquet Medical Systems USA is recalling Bubble Sensor (REF: 70105.5720) (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-1053-2024: Maquet Medical Systems USA is recalling Bubble Sensor (REF: 70105.5720)",
      "text": "The FDA logged enforcement record Z-1053-2024: Maquet Medical Systems USA is voluntarily recalling Bubble Sensor (REF: 70105.5720) — reason: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-28. Affected lots/codes: Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148;  SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097;. 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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1053-2024 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-1053-2024/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.",
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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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            "Value": "AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.",
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