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  "name": "ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;  Model no. 11328100",
  "description": "FDA recall Z-0523-2024 — Siemens Medical Solutions USA, Inc is recalling ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;  Model no. 11328100 (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": "ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;  Model no. 11328100",
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      "name": "FDA recall Z-0523-2024: Siemens Medical Solutions USA, Inc is recalling ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;  Model no. 11328100",
      "text": "The FDA logged enforcement record Z-0523-2024: Siemens Medical Solutions USA, Inc is voluntarily recalling ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;  Model no. 11328100 — reason: Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the \"override\" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-17. Affected lots/codes: UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0523-2024 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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      "@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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