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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1690-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):  1.\tAPC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply  \tModel: SCL500RM1U    2.\tAPC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply\t        Model: SCL500RMI1U",
  "description": "FDA recall Z-1690-2024 — Philips North America Llc is recalling Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):  1.\tAPC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply  \tModel: SCL500RM1U    2.\tAPC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply\t        Model: SCL500RMI1U (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": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):  1.\tAPC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply  \tModel: SCL500RM1U    2.\tAPC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply\t        Model: SCL500RMI1U",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Philips North America Llc"
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1690-2024/enforcement-record",
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      "name": "FDA recall Z-1690-2024: Philips North America Llc is recalling Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):  1.\tAPC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply  \tModel: SCL500RM1U    2.\tAPC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply\t        Model: SCL500RMI1U",
      "text": "The FDA logged enforcement record Z-1690-2024: Philips North America Llc is voluntarily recalling Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):  1.\tAPC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply  \tModel: SCL500RM1U    2.\tAPC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply\t        Model: SCL500RMI1U — reason: Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power.  may lead to the delay in the detection of a change in a patient condition. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-22. Affected lots/codes: 1. SCL500RM1U (only serial number date codes prior to 2237*)   2. SCL500RMI1U (only serial number date codes prior to 2241*)    Example unit serial number is 5S\"2104\"08943, meaning it was manufactured during week 04 of the year 2021. The serial number format is 5SYYWW123456.. 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-1690-2024&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-1690-2024&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."
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      "name": "FDA classified recall Z-1690-2024 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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        "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-1690-2024&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-1690-2024/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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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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      "name": "FDA recall details — Z-1690-2024",
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            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Philips North America Llc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power.  may lead to the delay in the detection of a change in a patient condition",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-03-22",
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            "Field": "Lot/code info",
            "Value": "1. SCL500RM1U (only serial number date codes prior to 2237*)   2. SCL500RMI1U (only serial number date codes prior to 2241*)    Example unit serial number is 5S\"2104\"08943, meaning it was manufactured during week 04 of the year 2021. The serial number format is 5SYYWW123456.",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia,  Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Czech Republic,  Ecuador, Estonia, Fiji, Finland, France, Germany, Greece, Hong Kong, India, Indonesia,  Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico,  Myanmar, Netherlands, New Zealand, Oman, Philippines, Poland, Portugal, Puerto Rico,  Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan,  United Kingdom, Utd. Ara Emir.",
            "Status": "recorded"
          }
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    }
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