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  "name": "Incisive CT for Brazil SKD-Computed Tomography X-Ray System   Model: 728146",
  "description": "FDA recall Z-2259-2023 — Philips North America is recalling Incisive CT for Brazil SKD-Computed Tomography X-Ray System   Model: 728146 (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-2259-2023: Philips North America is recalling Incisive CT for Brazil SKD-Computed Tomography X-Ray System   Model: 728146",
      "text": "The FDA logged enforcement record Z-2259-2023: Philips North America is voluntarily recalling Incisive CT for Brazil SKD-Computed Tomography X-Ray System   Model: 728146 — reason: Metal mounting box on the rotating scanner on rotor  (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down. Status: Ongoing — the recall is still being carried out.. Initiated 2023-04-25. Affected lots/codes: UDI-DI: (01)00884838104481(21) Serial Numbers: 540009 540008 540015 540012 540016 540017 540003 540004 540005 540006 540007 540001 540011 540000 540014 540013 540018 540010 540002. A RECORDED FDA enforcement action (occurred=true).",
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      "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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