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  "name": "Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System",
  "description": "FDA recall Z-2098-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine 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": "FDA recall Z-2098-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System",
      "text": "The FDA logged enforcement record Z-2098-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System — reason: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-20. Affected lots/codes: Serial Numbers:  Millennium VG 1074;  \"Varicam Millennium VG Discovery VH\" 1003 1092 10147 10242 10374 10378 10539 10543 10550 10553 10561 10569 10570 10571 10579 10582 10587 10599 10604 3101-1502. 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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-2098-2025 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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