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  "name": "Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.   Part Number: Part Number 115-066758-00",
  "description": "FDA recall Z-2951-2024 — Mindray DS USA, Inc. dba Mindray North America is recalling Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.   Part Number: Part Number 115-066758-00 (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",
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    "name": "Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.   Part Number: Part Number 115-066758-00",
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      "name": "Mindray DS USA, Inc. dba Mindray North America"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2951-2024/enforcement-record",
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      "name": "FDA recall Z-2951-2024: Mindray DS USA, Inc. dba Mindray North America is recalling Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.   Part Number: Part Number 115-066758-00",
      "text": "The FDA logged enforcement record Z-2951-2024: Mindray DS USA, Inc. dba Mindray North America is voluntarily recalling Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.   Part Number: Part Number 115-066758-00 — reason: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the  patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe  cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-22. Affected lots/codes: UDI-DI: 06936415975753 Serial Number:  AH6B24000165 AH6B24000170 AH6B24000167 AH6B24000163  AH6B24000166 AH6B24000173 AH6B24000174 AH6B24000183. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2951-2024&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-2951-2024&lang=eng"
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2951-2024/fda-classification",
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      "name": "FDA classified recall Z-2951-2024 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.",
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        "value": "Class II",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2951-2024/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.",
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        "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-2951-2024",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Mindray DS USA, Inc. dba Mindray North America",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the  patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe  cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention",
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            "Field": "Distribution pattern",
            "Value": "US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada",
            "Status": "recorded"
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