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  "name": "EVair 03 (Jun-air) air compressor, model numbers:  1609000 and 1609002",
  "description": "FDA recall Z-0775-2024 — Datex-Ohmeda, Inc. is recalling EVair 03 (Jun-air) air compressor, model numbers:  1609000 and 1609002 (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "EVair 03 (Jun-air) air compressor, model numbers:  1609000 and 1609002",
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      "name": "FDA recall Z-0775-2024: Datex-Ohmeda, Inc. is recalling EVair 03 (Jun-air) air compressor, model numbers:  1609000 and 1609002",
      "text": "The FDA logged enforcement record Z-0775-2024: Datex-Ohmeda, Inc. is voluntarily recalling EVair 03 (Jun-air) air compressor, model numbers:  1609000 and 1609002 — 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: UDI/DI ********, Serial Numbers:  CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, CBCU00559. A RECORDED FDA enforcement action (occurred=true).",
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      "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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-0775-2024 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.",
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      "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."
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      "@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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      "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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            "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.",
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