{
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    "@vocab": "https://schema.org/",
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    "supported": "au:supported",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0776-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "EvAir CPRSR Kit Upgrade:    a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;   b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849;   e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;",
  "description": "FDA recall Z-0776-2024 — Datex-Ohmeda, Inc. is recalling EvAir CPRSR Kit Upgrade:    a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;   b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849;   e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849; (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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-0776-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "EvAir CPRSR Kit Upgrade:    a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;   b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849;   e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Datex-Ohmeda, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0776-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0776-2024: Datex-Ohmeda, Inc. is recalling EvAir CPRSR Kit Upgrade:    a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;   b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849;   e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;",
      "text": "The FDA logged enforcement record Z-0776-2024: Datex-Ohmeda, Inc. is voluntarily recalling EvAir CPRSR Kit Upgrade:    a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;   b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849;   e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849; — reason: GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE  R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase,  minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde.  While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-29. Affected lots/codes: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers: GEB08691, GEB08778, GEB08726, GEB08791, GEB08782, GEB08780, GEB08651, GEB08694, GEB08776, GEA05881, GEA05877, GEA05883, GEA05882, GEA05880, GEA04101, GEA05302, GEA04586, GEA04621, GEA05372, GEA05304, GEA04587, GEA04556, GEA05369, GEA04588, GEA04620, GEA04098, GEA05303, GEA05301, GEA04618, GEA04619, GEA04099, GEA04589, GEA04100, GEB08768, GEA04550, GEA06057, GEA06119, GEA06116, GEA07318, GEA06709, GEA07513, GEA07155, GEA07162, GEA07434, GEA07428, GEA07433, GEA07511, GEA07431, GEA07568, GEA07528, GEA07152, GEA03205, GEA03202, GEA03204, GEA03203, GEA06055, GEA06117, GEA04802, GEA06118, GEA06056, GEA04553, GEA04800, GEA04803, GEA04801, GEA07822, GEA07842, GEA07840, GEA07839, GEA07851, GEA07804, GEA07901, GE021663, GE021666, GEA03006, GEA03008, GEA03007, GEA03005;    b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; UDI/DI *TBP* , Serial Numbers:  GEA07877, GEA07866, GEA08370, GEA08369, GEA07893, GEA07892, GEB08822, GEB08809, GEB08827, GEB08820, GEB08813, GEA06781, GEA06778, GEB08835, GEB08817, GEA07895, GEA07859, GEA07896, GEA07861, GEB08821;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers:  GEA06054, GEB08069, GEB07991, GEB07965, GEB08171, GEB08276, GEB07412, GEB07440, GEB03790, GEB08164, GEB07396, GEB08242, GEB08172, GEB08243, GEB08245, GEB08239, GE021229, GE021230, GEA04266, GEA04269, GEA04265, GEA04264, GEA04263, GEB09817, GEB09804, GEB09808, GEB09855, GEB09863, GEB09719, GEB09853, GEB09823, GEB09856, GEB09822, GEB08785, GEB08792, GEB08781;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers:  GEB09437, GEB09803, GEB09824, GEB09819, GEB09402, GEB09391, GEA07666, GEA07643, GEA07663, GEA07857, GEA07914, GEB09401, GEB09932, GEA07904, GEA07902, GEA07610, GEA07856, GEA07652, GEA07711, GEA07720, GEA07665, GEA07609, GEA07634, GEA07599, GEA07577, GEA07611, GEA07633, GEA07655, GEA07845, 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GEA07934, GEA07932, GEA07494, GEA08212, GEA08134, GEA08065, GEA08052, GEA08129, GEA08014, GEA08053, GEA07939, GEA06968, GEA07931, GEA06754, GEA07026, GEA08207, GEA08051, GEA08018, GEA08016, GEA07929, GEA08299, GEA07936, GEA08211, GEA07971, GEA08147, GEA08013, GEA08027, GEA08024, GEA08097, GEA08096, GEA08248, GEA08253, GEA08094, GEA07908, GEA08089, GEA08251, GEA08109, GEA08250, GEA08090, GEA08122, GEA03051. 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-0776-2024&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-0776-2024&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-0776-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0776-2024 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,
        "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-0776-2024&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-0776-2024&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-0776-2024/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",
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0776-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0776-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "Datex-Ohmeda, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE  R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase,  minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde.  While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-12-29",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
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GEA08369, GEA07893, GEA07892, GEB08822, GEB08809, GEB08827, GEB08820, GEB08813, GEA06781, GEA06778, GEB08835, GEB08817, GEA07895, GEA07859, GEA07896, GEA07861, GEB08821;   c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers:  GEA06054, GEB08069, GEB07991, GEB07965, GEB08171, GEB08276, GEB07412, GEB07440, GEB03790, GEB08164, GEB07396, GEB08242, GEB08172, GEB08243, GEB08245, GEB08239, GE021229, GE021230, GEA04266, GEA04269, GEA04265, GEA04264, GEA04263, GEB09817, GEB09804, GEB09808, GEB09855, GEB09863, GEB09719, GEB09853, GEB09823, GEB09856, GEB09822, GEB08785, GEB08792, GEB08781;   d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; UDI/DI *TBP* , Serial Numbers:  GEB09437, GEB09803, GEB09824, GEB09819, GEB09402, GEB09391, GEA07666, GEA07643, GEA07663, GEA07857, GEA07914, GEB09401, GEB09932, GEA07904, GEA07902, GEA07610, GEA07856, GEA07652, GEA07711, GEA07720, GEA07665, GEA07609, GEA07634, GEA07599, GEA07577, GEA07611, GEA07633, GEA07655, GEA07845, 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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}