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  "name": "ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Material Number: 11327700",
  "description": "FDA recall Z-2360-2023 — Siemens Medical Solutions USA, Inc is recalling ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Material Number: 11327700 (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-2360-2023: Siemens Medical Solutions USA, Inc is recalling ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Material Number: 11327700",
      "text": "The FDA logged enforcement record Z-2360-2023: Siemens Medical Solutions USA, Inc is voluntarily recalling ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Material Number: 11327700 — reason: Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-19. Affected lots/codes: UDI-DI: 4056869149325 Serial Numbers: 170561 170549 170559 170546 170552 170571 170570. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2360-2023 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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      "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": "Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system",
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