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  "name": "BVI Leos Laser and Endoscopy System. Model Number: OME6000U.",
  "description": "FDA recall Z-1008-2026 — Beaver-Visitec International, Inc. is recalling BVI Leos Laser and Endoscopy System. Model Number: OME6000U. (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-1008-2026: Beaver-Visitec International, Inc. is recalling BVI Leos Laser and Endoscopy System. Model Number: OME6000U.",
      "text": "The FDA logged enforcement record Z-1008-2026: Beaver-Visitec International, Inc. is voluntarily recalling BVI Leos Laser and Endoscopy System. Model Number: OME6000U. — reason: Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-05. Affected lots/codes: Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1008-2026 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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      "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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