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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2457-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Arctic Sun Temperature Management Systems, Name/REF:   Arctic Sun STAT, NA/6000-00-00;  Arctic Sun STAT Loaner, NA/6000-00-00L;  Arctic Sun Stat EU UK/600001;  Arctic Sun Stat Taiwan/600006;  Arctic Sun Stat Japan/600020;  Arctic Sun 5000, NA/5000-00-00;  Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E;  Loaner, Arctic Sun M5000, NA/5000-00-00L;  Arctic Sun 5000, EU/5000-1-01;  Loaner, Arctic Sun M5000, EU/5000-01-01L;  Arctic Sun 5000, UK/5000-01-02;  Arctic Sun 5000, Australia/5000-01-03;  Arctic Sun 5000, China/5000-01-04;  Arctic Sun 5000, Brazil/5000-01-05;  Arctic Sun 5000, Switzerland/5000-01-07;  Arctic Sun 5000, South Africa/5000-01-08",
  "description": "FDA recall Z-2457-2024 — Medivance Inc. is recalling Arctic Sun Temperature Management Systems, Name/REF:   Arctic Sun STAT, NA/6000-00-00;  Arctic Sun STAT Loaner, NA/6000-00-00L;  Arctic Sun Stat EU UK/600001;  Arctic Sun Stat Taiwan/600006;  Arctic Sun Stat Japan/600020;  Arctic Sun 5000, NA/5000-00-00;  Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E;  Loaner, Arctic Sun M5000, NA/5000-00-00L;  Arctic Sun 5000, EU/5000-1-01;  Loaner, Arctic Sun M5000, EU/5000-01-01L;  Arctic Sun 5000, UK/5000-01-02;  Arctic Sun 5000, Australia/5000-01-03;  Arctic Sun 5000, China/5000-01-04;  Arctic Sun 5000, Brazil/5000-01-05;  Arctic Sun 5000, Switzerland/5000-01-07;  Arctic Sun 5000, South Africa/5000-01-08 (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2457-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Arctic Sun Temperature Management Systems, Name/REF:   Arctic Sun STAT, NA/6000-00-00;  Arctic Sun STAT Loaner, NA/6000-00-00L;  Arctic Sun Stat EU UK/600001;  Arctic Sun Stat Taiwan/600006;  Arctic Sun Stat Japan/600020;  Arctic Sun 5000, NA/5000-00-00;  Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E;  Loaner, Arctic Sun M5000, NA/5000-00-00L;  Arctic Sun 5000, EU/5000-1-01;  Loaner, Arctic Sun M5000, EU/5000-01-01L;  Arctic Sun 5000, UK/5000-01-02;  Arctic Sun 5000, Australia/5000-01-03;  Arctic Sun 5000, China/5000-01-04;  Arctic Sun 5000, Brazil/5000-01-05;  Arctic Sun 5000, Switzerland/5000-01-07;  Arctic Sun 5000, South Africa/5000-01-08",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medivance Inc."
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  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2457-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2457-2024: Medivance Inc. is recalling Arctic Sun Temperature Management Systems, Name/REF:   Arctic Sun STAT, NA/6000-00-00;  Arctic Sun STAT Loaner, NA/6000-00-00L;  Arctic Sun Stat EU UK/600001;  Arctic Sun Stat Taiwan/600006;  Arctic Sun Stat Japan/600020;  Arctic Sun 5000, NA/5000-00-00;  Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E;  Loaner, Arctic Sun M5000, NA/5000-00-00L;  Arctic Sun 5000, EU/5000-1-01;  Loaner, Arctic Sun M5000, EU/5000-01-01L;  Arctic Sun 5000, UK/5000-01-02;  Arctic Sun 5000, Australia/5000-01-03;  Arctic Sun 5000, China/5000-01-04;  Arctic Sun 5000, Brazil/5000-01-05;  Arctic Sun 5000, Switzerland/5000-01-07;  Arctic Sun 5000, South Africa/5000-01-08",
      "text": "The FDA logged enforcement record Z-2457-2024: Medivance Inc. is voluntarily recalling Arctic Sun Temperature Management Systems, Name/REF:   Arctic Sun STAT, NA/6000-00-00;  Arctic Sun STAT Loaner, NA/6000-00-00L;  Arctic Sun Stat EU UK/600001;  Arctic Sun Stat Taiwan/600006;  Arctic Sun Stat Japan/600020;  Arctic Sun 5000, NA/5000-00-00;  Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E;  Loaner, Arctic Sun M5000, NA/5000-00-00L;  Arctic Sun 5000, EU/5000-1-01;  Loaner, Arctic Sun M5000, EU/5000-01-01L;  Arctic Sun 5000, UK/5000-01-02;  Arctic Sun 5000, Australia/5000-01-03;  Arctic Sun 5000, China/5000-01-04;  Arctic Sun 5000, Brazil/5000-01-05;  Arctic Sun 5000, Switzerland/5000-01-07;  Arctic Sun 5000, South Africa/5000-01-08 — reason: If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-27. Affected lots/codes: REF/UDI-DI/Software: 6000-00-00/00801741161513/v1.0.5 and prior, 6000-00-00L/00801741161520/v1.0.5 and prior, 600001/00801741226380/v2.1.1.0 and prior, 600006/00801741226397/v2.1.1.0 and prior, 600020/00801741226403/v2.1.1.0 and prior, 5000-00-00/00801741080142/v3.0.2 and prior, 5000-00-00E/00801741127755/v3.0.2 and prior, 5000-00-00L/00801741080159/v3.0.2 and prior, 5000-1-01/00801741186134/v3.0.2 and prior, 5000-01-01L/00801741186141/v3.0.2 and prior, 5000-01-02/00801741170003/v3.0.2 and prior, 5000-01-03/00801741222818/v3.0.2 and prior, 5000-01-04/00801741144653/v4.0.0 and prior, 5000-01-05/00801741222825/v3.0.2 and prior, 5000-01-07/00801741222832/v3.0.2 and prior, 5000-01-08/00801741222849/v3.0.2 and prior  All serial numbers.. 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": {
        "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-2457-2024&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-2457-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2457-2024/fda-classification",
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      "name": "FDA classified recall Z-2457-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-2457-2024&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-2457-2024&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-2457-2024/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",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "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-2457-2024",
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            "Value": "Z-2457-2024",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "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"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medivance Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-06-27",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI/Software: 6000-00-00/00801741161513/v1.0.5 and prior, 6000-00-00L/00801741161520/v1.0.5 and prior, 600001/00801741226380/v2.1.1.0 and prior, 600006/00801741226397/v2.1.1.0 and prior, 600020/00801741226403/v2.1.1.0 and prior, 5000-00-00/00801741080142/v3.0.2 and prior, 5000-00-00E/00801741127755/v3.0.2 and prior, 5000-00-00L/00801741080159/v3.0.2 and prior, 5000-1-01/00801741186134/v3.0.2 and prior, 5000-01-01L/00801741186141/v3.0.2 and prior, 5000-01-02/00801741170003/v3.0.2 and prior, 5000-01-03/00801741222818/v3.0.2 and prior, 5000-01-04/00801741144653/v4.0.0 and prior, 5000-01-05/00801741222825/v3.0.2 and prior, 5000-01-07/00801741222832/v3.0.2 and prior, 5000-01-08/00801741222849/v3.0.2 and prior  All serial numbers.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of IN, OK, MO, FL, CT, KS, TX, NJ, CA, OR, HI, IL, WI, VA, KY, NH, CO, NV, LA, NC, ID, UT, GA, SC, TN, MD, PA, IA, MA, OH, NY, DE, MI, NM, WV, AZ, DC, VT, MN, SD, AL, AR, WA, NE, ND, MT, AK, MS, ME, WY, RI, PR, OK, OR and the countries of CA, DE, AT, BE, FI, TR, NO, DK, JP, ES, AU, FR, GB, IT, SE, PT, AE, SA, ZA, RU, KR, CY, TH, GR, TW, MY, OM, CN, SG, GI, NL, IL, CZ, RO, CH, RE, PL, PE, SK, AR, IN, CL, MX, QA, BR, SI, HU, JO, LU, KW, PH, NZ, HK, VN, IR, BN, UA, ID, CO, KZ, HR, IS, GU, GE, BH, EE, AM, PA, KR, CL, TH, MY, JP, AU, BD, BE, TW",
            "Status": "recorded"
          }
        }
      ]
    }
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}