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  "name": "BrightView X, Gamma Camera, Product Code 882478",
  "description": "FDA recall Z-0678-2024 — Philips North America is recalling BrightView X, Gamma Camera, Product Code 882478 (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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0678-2024/enforcement-record",
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      "name": "FDA recall Z-0678-2024: Philips North America is recalling BrightView X, Gamma Camera, Product Code 882478",
      "text": "The FDA logged enforcement record Z-0678-2024: Philips North America is voluntarily recalling BrightView X, Gamma Camera, Product Code 882478 — reason: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or  contusion.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-30. Affected lots/codes: No UDI  Serial numbers 11000072 11000116 11000007 11000010 11340001 11000027 11000032 4000570 11000041 11000092 11000113 11340003 11000044 11000006 11000033 11000025 11000105 11000016 11000003 11000018 11000065 11000047 11000066 11000101 11000107 11000090 11000029 11000056 11000026 11000046 11000051 11000078 11000114 11000067 11000050 11000084 11000068 11000052 11000057 11000055 11000070 11000088 11000023 11000061 11000060 11000095 11000094 11000102 11000054 11340004 11000091 11000083 11000098 11000063 11000013 11000015 11000062 11000035 11000081 11000009 11000017 11000110 11000004 11000008 11000005 11000020 11000011 11000014 11000012 11000019 11000022 11000031 11000024 11000034 11000036 11000028 11000030 11340002 11000042 11000037 11000080 11000079 11000039 11000040 11000069 11000038 11000045 11000086 11000049 11000043 11000048 11000059 11000058 11000097 11000096 11000073 11000074 11000071 11000064 11000075 11340005 11000077 11000076 11000089 11000087 11000085 11000106 11000100 11000093 11000104 11000099 11000103 11000115 11000112 11000109 11000117 11000108 11000118. A RECORDED FDA enforcement action (occurred=true).",
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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-0678-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-0678-2024 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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        }
      },
      "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-0678-2024/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",
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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": "While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or  contusion.",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic distribution nationwide. Foreign distribution worldwide.",
            "Status": "recorded"
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