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  "name": "Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:    1. Allura Xper FD10, Model Number 722003.     2. Allura Xper FD10/10, Model Number 722005.     3. Allura Xper FD20, Model Number 722006.     4. Allura Xper FD20 Biplane, Model Number 722008.     5. Allura Xper FD10, Model Number 722010.     6. Allura Xper FD10/10, Model Number 722011.     7. Allura Xper FD20, Model Number 722012.     8. Allura Xper FD20 Biplane, Model Number 722013.     9. Allura Xper FD20 OR Table, Model Number 722023.     10. Allura Xper FD10, Model Number 722026.     11. Allura Xper FD10/10, Model Number 722027.     12. Allura Xper FD20, Model Number 722028.     13. Allura Xper FD20/10, Model Number 722029.     14. Allura Xper FD20 OR Table, Model Number 722035.     15. Allura Xper FD20/20, Model Number 722038.     16. Allura Xper FD20/15, Model Number 722058.    510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.",
  "description": "FDA recall Z-2504-2025 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:    1. Allura Xper FD10, Model Number 722003.     2. Allura Xper FD10/10, Model Number 722005.     3. Allura Xper FD20, Model Number 722006.     4. Allura Xper FD20 Biplane, Model Number 722008.     5. Allura Xper FD10, Model Number 722010.     6. Allura Xper FD10/10, Model Number 722011.     7. Allura Xper FD20, Model Number 722012.     8. Allura Xper FD20 Biplane, Model Number 722013.     9. Allura Xper FD20 OR Table, Model Number 722023.     10. Allura Xper FD10, Model Number 722026.     11. Allura Xper FD10/10, Model Number 722027.     12. Allura Xper FD20, Model Number 722028.     13. Allura Xper FD20/10, Model Number 722029.     14. Allura Xper FD20 OR Table, Model Number 722035.     15. Allura Xper FD20/20, Model Number 722038.     16. Allura Xper FD20/15, Model Number 722058.    510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859. (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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    "@type": "schema:MedicalDevice",
    "name": "Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:    1. Allura Xper FD10, Model Number 722003.     2. Allura Xper FD10/10, Model Number 722005.     3. Allura Xper FD20, Model Number 722006.     4. Allura Xper FD20 Biplane, Model Number 722008.     5. Allura Xper FD10, Model Number 722010.     6. Allura Xper FD10/10, Model Number 722011.     7. Allura Xper FD20, Model Number 722012.     8. Allura Xper FD20 Biplane, Model Number 722013.     9. Allura Xper FD20 OR Table, Model Number 722023.     10. Allura Xper FD10, Model Number 722026.     11. Allura Xper FD10/10, Model Number 722027.     12. Allura Xper FD20, Model Number 722028.     13. Allura Xper FD20/10, Model Number 722029.     14. Allura Xper FD20 OR Table, Model Number 722035.     15. Allura Xper FD20/20, Model Number 722038.     16. Allura Xper FD20/15, Model Number 722058.    510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2504-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2504-2025: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:    1. Allura Xper FD10, Model Number 722003.     2. Allura Xper FD10/10, Model Number 722005.     3. Allura Xper FD20, Model Number 722006.     4. Allura Xper FD20 Biplane, Model Number 722008.     5. Allura Xper FD10, Model Number 722010.     6. Allura Xper FD10/10, Model Number 722011.     7. Allura Xper FD20, Model Number 722012.     8. Allura Xper FD20 Biplane, Model Number 722013.     9. Allura Xper FD20 OR Table, Model Number 722023.     10. Allura Xper FD10, Model Number 722026.     11. Allura Xper FD10/10, Model Number 722027.     12. Allura Xper FD20, Model Number 722028.     13. Allura Xper FD20/10, Model Number 722029.     14. Allura Xper FD20 OR Table, Model Number 722035.     15. Allura Xper FD20/20, Model Number 722038.     16. Allura Xper FD20/15, Model Number 722058.    510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.",
      "text": "The FDA logged enforcement record Z-2504-2025: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:    1. Allura Xper FD10, Model Number 722003.     2. Allura Xper FD10/10, Model Number 722005.     3. Allura Xper FD20, Model Number 722006.     4. Allura Xper FD20 Biplane, Model Number 722008.     5. Allura Xper FD10, Model Number 722010.     6. Allura Xper FD10/10, Model Number 722011.     7. Allura Xper FD20, Model Number 722012.     8. Allura Xper FD20 Biplane, Model Number 722013.     9. Allura Xper FD20 OR Table, Model Number 722023.     10. Allura Xper FD10, Model Number 722026.     11. Allura Xper FD10/10, Model Number 722027.     12. Allura Xper FD20, Model Number 722028.     13. Allura Xper FD20/10, Model Number 722029.     14. Allura Xper FD20 OR Table, Model Number 722035.     15. Allura Xper FD20/20, Model Number 722038.     16. Allura Xper FD20/15, Model Number 722058.    510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859. — reason: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-01. Affected lots/codes: 1. Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077, 464.  2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI); 54.  3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 2126, 2200, 1560, 1921, 1724, 1219.  4. Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 516, 142, 434, 418, 480.  5.  Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840, 413.  6.  Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308, 344, 243, 266, 231, 286, 369, 378, 259, 333.  7.  Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667.  8.  Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 115, 575, 272, 632, 378, 608, 412, 353, 595, 355, 403.  9.  Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 128, 83, 86, 134, 87.  10.  Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 233, 561, 942, 368, 826, 1115, 539, 159, 598, 365, 528, 603, 263, 792, 783, 679, 680, 406, 388, 302, 659, 736, 1022, 22, 506, 120, 526.  11.  Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 106, 127, 78, 204, 113, 82, 66, 119.  12.  Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 668, 265, 1154, 180, 880, 274, 172, 1111, 806, 451, 236, 887, 874, 1266, 1499, 1514, 1457, 908, 1292, 247, 944, 951, 1390, 1662, 415, 105, 1675, 348, 1562, 1029, 51, 941, 403, 427, 659, 935, 1225, 1165, 1621, 725, 723, 1559, 753, 883.  13.  Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 69, 58.  14.  Model Number/System Code (UDI); Serial Numbers: 722035 (00884838054240); 187, 125, 40, 108, 163, 26, 75, 173, 190, 103.  15.  Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226); 63.  16.  Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 238, 161, 84, 39, 133, 244, 193, 187, 102.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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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-2504-2025&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-2504-2025&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-2504-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2504-2025 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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        "value": "Class II",
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          "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-2504-2025&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-2504-2025/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,
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      "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-2504-2025",
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            "Value": "Z-2504-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
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            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-08-01",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "1. Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077, 464.  2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI); 54.  3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 2126, 2200, 1560, 1921, 1724, 1219.  4. Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 516, 142, 434, 418, 480.  5.  Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840, 413.  6.  Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308, 344, 243, 266, 231, 286, 369, 378, 259, 333.  7.  Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667.  8.  Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 115, 575, 272, 632, 378, 608, 412, 353, 595, 355, 403.  9.  Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 128, 83, 86, 134, 87.  10.  Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 233, 561, 942, 368, 826, 1115, 539, 159, 598, 365, 528, 603, 263, 792, 783, 679, 680, 406, 388, 302, 659, 736, 1022, 22, 506, 120, 526.  11.  Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 106, 127, 78, 204, 113, 82, 66, 119.  12.  Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 668, 265, 1154, 180, 880, 274, 172, 1111, 806, 451, 236, 887, 874, 1266, 1499, 1514, 1457, 908, 1292, 247, 944, 951, 1390, 1662, 415, 105, 1675, 348, 1562, 1029, 51, 941, 403, 427, 659, 935, 1225, 1165, 1621, 725, 723, 1559, 753, 883.  13.  Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 69, 58.  14.  Model Number/System Code (UDI); Serial Numbers: 722035 (00884838054240); 187, 125, 40, 108, 163, 26, 75, 173, 190, 103.  15.  Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226); 63.  16.  Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 238, 161, 84, 39, 133, 244, 193, 187, 102.",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium, Switzerland, Chile, China, Colombia, Czechia, Germany, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, India, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Norway, Oman, Pakistan, Poland, Romania, Saudi Arabia, Sweden, Singapore, Thailand, Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}