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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0559-2024.jsonld",
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  "name": "Philips Azurion systems with monoplane fixed ceiling mounts:  722078 Azurion 7 M12  722079 Azurion 7 M20  722223 Azurion 7 M12  722224 Azurion 7 M20  722227 Azurion 5 M12  722228 Azurion 5 M20",
  "description": "FDA recall Z-0559-2024 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion systems with monoplane fixed ceiling mounts:  722078 Azurion 7 M12  722079 Azurion 7 M20  722223 Azurion 7 M12  722224 Azurion 7 M20  722227 Azurion 5 M12  722228 Azurion 5 M20 (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "Philips Azurion systems with monoplane fixed ceiling mounts:  722078 Azurion 7 M12  722079 Azurion 7 M20  722223 Azurion 7 M12  722224 Azurion 7 M20  722227 Azurion 5 M12  722228 Azurion 5 M20",
    "manufacturer": {
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      "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0559-2024/enforcement-record",
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      "name": "FDA recall Z-0559-2024: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion systems with monoplane fixed ceiling mounts:  722078 Azurion 7 M12  722079 Azurion 7 M20  722223 Azurion 7 M12  722224 Azurion 7 M20  722227 Azurion 5 M12  722228 Azurion 5 M20",
      "text": "The FDA logged enforcement record Z-0559-2024: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Philips Azurion systems with monoplane fixed ceiling mounts:  722078 Azurion 7 M12  722079 Azurion 7 M20  722223 Azurion 7 M12  722224 Azurion 7 M20  722227 Azurion 5 M12  722228 Azurion 5 M20 — reason: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-03. Affected lots/codes: Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 722223 Azurion 7 M12 (01)00884838099241(21); 722224 Azurion 7 M20 (01)00884838099258(21); 722227 Azurion 5 M12 (01)00884838099227(21); 722228 Azurion 5 M20 (01)00884838099234(21).. A RECORDED FDA enforcement action (occurred=true).",
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0559-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0559-2024&lang=eng"
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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-0559-2024 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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      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0559-2024/boundary",
      "@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": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose",
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            "Field": "Lot/code info",
            "Value": "Mdoel/Product Name/UDI-DI: 722078 Azurion 7 M12 (01)00884838085251(21); 722079 Azurion 7 M20 (01)00884838085268(21); 722223 Azurion 7 M12 (01)00884838099241(21); 722224 Azurion 7 M20 (01)00884838099258(21); 722227 Azurion 5 M12 (01)00884838099227(21); 722228 Azurion 5 M20 (01)00884838099234(21).",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia,  Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic,  Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia,  Germany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong,  Hungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan,  Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritius,  Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand,  Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea,  Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, 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,  Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay,  Uzbekistan, Venezuela, Vietnam, Yemen.",
            "Status": "recorded"
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