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  "name": "PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE",
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      "name": "FDA recall Z-0418-2024: Aizu Olympus Co., Ltd. is recalling PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE",
      "text": "The FDA logged enforcement record Z-0418-2024: Aizu Olympus Co., Ltd. is voluntarily recalling PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE — reason: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-16. Affected lots/codes: UDI-DI 04953170363672 Serial Numbers 2942716, 2604497, 2502056. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0418-2024 as Class II",
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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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