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  "name": "Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.",
  "description": "FDA recall Z-2489-2023 — Accuray Incorporated is recalling Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. (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": "Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.",
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      "name": "Accuray Incorporated"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2489-2023/enforcement-record",
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      "name": "FDA recall Z-2489-2023: Accuray Incorporated is recalling Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.",
      "text": "The FDA logged enforcement record Z-2489-2023: Accuray Incorporated is voluntarily recalling Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. — reason: It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2023-08-03. Affected lots/codes: UDI-DI number 00811376030009.  Serial numbers 4010505, 4010506, 4010507, 4010508, 4010509, 4010510, 4010511, 4010513, 4010515, 4010516, 4010517, 4010518, 4010519, 4010521, 4010522, 4010523, 4010524, 4010525, 4010526, 4010527, 4010528, 4010529, 4010530, 4010531, 4010532, 4010533, 4010536, 4010537, 4010538, 4010539, 4010541, 4010542, 4010543, 4010544, 4010545, 4010546, 4010548, 4010549, 4010550, 4010551, 4010552, 4010553, 4010554, 4010555, 4010556, 4010557, 4010558, 4010559, 4010560, 4010561, 4010562, 4010563, 4010564, 4010565, 4010566, 4010567, 4010568, 4010569, 4010570, 4010571, 4010573, 4010574, 4010577, 4010579, 4010582, 4010583, 4010584, 4010585, 4010586, 4010587, 4010588, 4010589, 4010590, 4010592, 4010593, 4010594, 4010596, 4010599, 4010607, 4010600, 4010601, and 4010609.. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": 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-2489-2023&lang=eng",
        "value": "Devices recall, status Completed",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2489-2023&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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      "name": "FDA classified recall Z-2489-2023 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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        }
      },
      "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-2489-2023/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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            "Value": "Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Accuray Incorporated",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2023-08-03",
            "Status": "recorded"
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            "Value": "UDI-DI number 00811376030009.  Serial numbers 4010505, 4010506, 4010507, 4010508, 4010509, 4010510, 4010511, 4010513, 4010515, 4010516, 4010517, 4010518, 4010519, 4010521, 4010522, 4010523, 4010524, 4010525, 4010526, 4010527, 4010528, 4010529, 4010530, 4010531, 4010532, 4010533, 4010536, 4010537, 4010538, 4010539, 4010541, 4010542, 4010543, 4010544, 4010545, 4010546, 4010548, 4010549, 4010550, 4010551, 4010552, 4010553, 4010554, 4010555, 4010556, 4010557, 4010558, 4010559, 4010560, 4010561, 4010562, 4010563, 4010564, 4010565, 4010566, 4010567, 4010568, 4010569, 4010570, 4010571, 4010573, 4010574, 4010577, 4010579, 4010582, 4010583, 4010584, 4010585, 4010586, 4010587, 4010588, 4010589, 4010590, 4010592, 4010593, 4010594, 4010596, 4010599, 4010607, 4010600, 4010601, and 4010609.",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.",
            "Status": "recorded"
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