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  "name": "bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator",
  "description": "FDA recall Z-1967-2023 — Vyaire Medical is recalling bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator (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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    "name": "bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator",
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      "name": "FDA recall Z-1967-2023: Vyaire Medical is recalling bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator",
      "text": "The FDA logged enforcement record Z-1967-2023: Vyaire Medical is voluntarily recalling bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator — reason: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e:  1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states  DeviceSoftware.Application is not responding  or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error.  2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2023-05-05. Affected lots/codes: UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Completed",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-1967-2023 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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      "@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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            "Value": "Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e:  1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states  DeviceSoftware.Application is not responding  or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error.  2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.",
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