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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1647-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:\t722063, 722221;  (2) Azurion 3M15:\t722064, 722222;  (3) Azurion SM12:\t722227;  (4) Azurion SM20:\t722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:\t722068, 722226;  (7) Azurion 7M12:\t722078, 722223;  (8) Azurion 7M20\t:\t722079, 722224",
  "description": "FDA recall Z-1647-2023 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:\t722063, 722221;  (2) Azurion 3M15:\t722064, 722222;  (3) Azurion SM12:\t722227;  (4) Azurion SM20:\t722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:\t722068, 722226;  (7) Azurion 7M12:\t722078, 722223;  (8) Azurion 7M20\t:\t722079, 722224 (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-1647-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:\t722063, 722221;  (2) Azurion 3M15:\t722064, 722222;  (3) Azurion SM12:\t722227;  (4) Azurion SM20:\t722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:\t722068, 722226;  (7) Azurion 7M12:\t722078, 722223;  (8) Azurion 7M20\t:\t722079, 722224",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1647-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1647-2023: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:\t722063, 722221;  (2) Azurion 3M15:\t722064, 722222;  (3) Azurion SM12:\t722227;  (4) Azurion SM20:\t722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:\t722068, 722226;  (7) Azurion 7M12:\t722078, 722223;  (8) Azurion 7M20\t:\t722079, 722224",
      "text": "The FDA logged enforcement record Z-1647-2023: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:\t722063, 722221;  (2) Azurion 3M15:\t722064, 722222;  (3) Azurion SM12:\t722227;  (4) Azurion SM20:\t722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:\t722068, 722226;  (7) Azurion 7M12:\t722078, 722223;  (8) Azurion 7M20\t:\t722079, 722224 — reason: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available  there will be a sudden interruption of the procedure. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-21. Affected lots/codes: UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063  (01)00884838085275(21)  722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion  SM12:  722227 (01)00884838099227(21); (4) Azurion  SM20:  722228 (01)00884838099234(21); (5) Azurion  7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15:  722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12:  722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21),     Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-1647-2023&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-1647-2023&lang=eng"
        }
      },
      "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-1647-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1647-2023 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1647-2023&lang=eng",
        "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-1647-2023&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-1647-2023/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",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "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-1647-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1647-2023",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available  there will be a sudden interruption of the procedure",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-03-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063  (01)00884838085275(21)  722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion  SM12:  722227 (01)00884838099227(21); (4) Azurion  SM20:  722228 (01)00884838099234(21); (5) Azurion  7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15:  722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12:  722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21),     Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide  Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}