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  "name": "ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system  Ref:706150",
  "description": "FDA recall Z-1073-2024 — Philips North America is recalling ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system  Ref:706150 (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-1073-2024: Philips North America is recalling ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system  Ref:706150",
      "text": "The FDA logged enforcement record Z-1073-2024: Philips North America is voluntarily recalling ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system  Ref:706150 — reason: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image.  Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB). Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-15. Affected lots/codes: UDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1073-2024 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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            "Value": "Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand",
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