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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0960-2025.jsonld",
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  "name": "VDR4 Phasitron Breathing Circuit Models that contain the venturi component:  -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk  -A51001, VDR4  Control Unit Tester  -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON  -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10  -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10    The Phasitron breathing circuit kit is intended to be used for  continuous ventilation intended for controlled ventilation of patients",
  "description": "FDA recall Z-0960-2025 — Percussionaire Corporation is recalling VDR4 Phasitron Breathing Circuit Models that contain the venturi component:  -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk  -A51001, VDR4  Control Unit Tester  -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON  -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10  -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10    The Phasitron breathing circuit kit is intended to be used for  continuous ventilation intended for controlled ventilation of patients (Devices, Class I). 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": {
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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-0960-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "VDR4 Phasitron Breathing Circuit Models that contain the venturi component:  -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk  -A51001, VDR4  Control Unit Tester  -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON  -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10  -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10    The Phasitron breathing circuit kit is intended to be used for  continuous ventilation intended for controlled ventilation of patients",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Percussionaire Corporation"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0960-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0960-2025: Percussionaire Corporation is recalling VDR4 Phasitron Breathing Circuit Models that contain the venturi component:  -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk  -A51001, VDR4  Control Unit Tester  -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON  -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10  -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10    The Phasitron breathing circuit kit is intended to be used for  continuous ventilation intended for controlled ventilation of patients",
      "text": "The FDA logged enforcement record Z-0960-2025: Percussionaire Corporation is voluntarily recalling VDR4 Phasitron Breathing Circuit Models that contain the venturi component:  -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk  -A51001, VDR4  Control Unit Tester  -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON  -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10  -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10    The Phasitron breathing circuit kit is intended to be used for  continuous ventilation intended for controlled ventilation of patients — reason: Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-23. Affected lots/codes: -Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696  - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701  - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733  - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667  - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "occurred": true,
        "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-0960-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0960-2025&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-0960-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0960-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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,
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        "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-0960-2025&lang=eng",
        "value": "Class I",
        "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-0960-2025&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-0960-2025/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": {
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        "supported": true,
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        "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-0960-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0960-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Percussionaire Corporation",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-12-23",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "-Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696  - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701  - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733  - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667  - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey.",
            "Status": "recorded"
          }
        }
      ]
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}