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  "name": "Azurion 7 B12\t    System Code:\t  (1) 722067  (2)\t722225  (3)\t722235",
  "description": "FDA recall Z-1091-2025 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Azurion 7 B12\t    System Code:\t  (1) 722067  (2)\t722225  (3)\t722235 (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": "Azurion 7 B12\t    System Code:\t  (1) 722067  (2)\t722225  (3)\t722235",
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      "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
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      "name": "FDA recall Z-1091-2025: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Azurion 7 B12\t    System Code:\t  (1) 722067  (2)\t722225  (3)\t722235",
      "text": "The FDA logged enforcement record Z-1091-2025: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Azurion 7 B12\t    System Code:\t  (1) 722067  (2)\t722225  (3)\t722235 — reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-13. Affected lots/codes: UDI:  (1) 722067 00884838085350(21); (2) 722225 00884838099265(21); (3) 722235 00884838116788(21). A RECORDED FDA enforcement action (occurred=true).",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-1091-2025 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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            "Field": "Reason",
            "Value": "Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel",
            "Status": "recorded"
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            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan,  Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh,  Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria,  Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia,  Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia,  Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar,  Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland,  India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan,  Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives,  Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar,  Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines,  Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden,  Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago,  Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay,  Uzbekistan, Venezuela, Viet Nam, Yemen.",
            "Status": "recorded"
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