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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0558-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Philips Allura  systems with monoplane fixed ceiling mounts:  722001 Allura Xper FD10C  722003 Allura Xper FD10  722006 Allura Xper FD20  722010 Allura Xper FD10  722012 Allura Xper FD20  722015 Allura Xper FD20 OR Table  722016 Integris H5000 C / Allura 9C  722018 Integris Allura 9  722022 Allura Xper FD10 OR Table  722023 Allura Xper FD20 OR Table  722026 Allura Xper FD10  722028 Allura Xper FD20  722033 Allura Xper FD10 OR Table  722035 Allura Xper FD20 OR Table  722043 Integris Allura 15 & 12 (monoplane)  72246 Poly G - OMCP - VISUB - CCD (H5000)",
  "description": "FDA recall Z-0558-2024 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Allura  systems with monoplane fixed ceiling mounts:  722001 Allura Xper FD10C  722003 Allura Xper FD10  722006 Allura Xper FD20  722010 Allura Xper FD10  722012 Allura Xper FD20  722015 Allura Xper FD20 OR Table  722016 Integris H5000 C / Allura 9C  722018 Integris Allura 9  722022 Allura Xper FD10 OR Table  722023 Allura Xper FD20 OR Table  722026 Allura Xper FD10  722028 Allura Xper FD20  722033 Allura Xper FD10 OR Table  722035 Allura Xper FD20 OR Table  722043 Integris Allura 15 & 12 (monoplane)  72246 Poly G - OMCP - VISUB - CCD (H5000) (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0558-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Philips Allura  systems with monoplane fixed ceiling mounts:  722001 Allura Xper FD10C  722003 Allura Xper FD10  722006 Allura Xper FD20  722010 Allura Xper FD10  722012 Allura Xper FD20  722015 Allura Xper FD20 OR Table  722016 Integris H5000 C / Allura 9C  722018 Integris Allura 9  722022 Allura Xper FD10 OR Table  722023 Allura Xper FD20 OR Table  722026 Allura Xper FD10  722028 Allura Xper FD20  722033 Allura Xper FD10 OR Table  722035 Allura Xper FD20 OR Table  722043 Integris Allura 15 & 12 (monoplane)  72246 Poly G - OMCP - VISUB - CCD (H5000)",
    "manufacturer": {
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      "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0558-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0558-2024: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Allura  systems with monoplane fixed ceiling mounts:  722001 Allura Xper FD10C  722003 Allura Xper FD10  722006 Allura Xper FD20  722010 Allura Xper FD10  722012 Allura Xper FD20  722015 Allura Xper FD20 OR Table  722016 Integris H5000 C / Allura 9C  722018 Integris Allura 9  722022 Allura Xper FD10 OR Table  722023 Allura Xper FD20 OR Table  722026 Allura Xper FD10  722028 Allura Xper FD20  722033 Allura Xper FD10 OR Table  722035 Allura Xper FD20 OR Table  722043 Integris Allura 15 & 12 (monoplane)  72246 Poly G - OMCP - VISUB - CCD (H5000)",
      "text": "The FDA logged enforcement record Z-0558-2024: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Philips Allura  systems with monoplane fixed ceiling mounts:  722001 Allura Xper FD10C  722003 Allura Xper FD10  722006 Allura Xper FD20  722010 Allura Xper FD10  722012 Allura Xper FD20  722015 Allura Xper FD20 OR Table  722016 Integris H5000 C / Allura 9C  722018 Integris Allura 9  722022 Allura Xper FD10 OR Table  722023 Allura Xper FD20 OR Table  722026 Allura Xper FD10  722028 Allura Xper FD20  722033 Allura Xper FD10 OR Table  722035 Allura Xper FD20 OR Table  722043 Integris Allura 15 & 12 (monoplane)  72246 Poly G - OMCP - VISUB - CCD (H5000) — 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: Model/Name/UDI-DI: 722001 Allura Xper FD10C;  722003 Allura Xper FD10;  722006 Allura Xper FD20 (01)00884838059115(21); 722010 Allura Xper FD10 (01)00884838059030(21); 722012 Allura Xper FD20 (01)00884838059054(21); 722015 Allura Xper FD20 OR Table;  722016 Integris H5000 C / Allura 9C ;  722018 Integris Allura 9; -  722022 Allura Xper FD10 OR Table;  722023 Allura Xper FD20 OR Table (01)00884838059085(21;) 722026 Allura Xper FD10 (01)00884838054189(21); 722028 Allura Xper FD20 (01)00884838054202(21); 722035 Allura Xper FD20 OR Table (01)00884838054240(21); 722043 Integris Allura 15 & 12 (monoplane).. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
        "operative": 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-0558-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-0558-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0558-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0558-2024 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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        "adjudged": true,
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0558-2024&lang=eng"
        }
      },
      "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-0558-2024/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.",
      "claimType": "interpretation",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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      "name": "FDA recall details — Z-0558-2024",
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            "Value": "Z-0558-2024",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "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",
            "Status": "recorded"
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2023-11-03",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model/Name/UDI-DI: 722001 Allura Xper FD10C;  722003 Allura Xper FD10;  722006 Allura Xper FD20 (01)00884838059115(21); 722010 Allura Xper FD10 (01)00884838059030(21); 722012 Allura Xper FD20 (01)00884838059054(21); 722015 Allura Xper FD20 OR Table;  722016 Integris H5000 C / Allura 9C ;  722018 Integris Allura 9; -  722022 Allura Xper FD10 OR Table;  722023 Allura Xper FD20 OR Table (01)00884838059085(21;) 722026 Allura Xper FD10 (01)00884838054189(21); 722028 Allura Xper FD20 (01)00884838054202(21); 722035 Allura Xper FD20 OR Table (01)00884838054240(21); 722043 Integris Allura 15 & 12 (monoplane).",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        }
      ]
    }
  ]
}