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  "name": "Model Number 40KWFXPLUS, Mobile X-ray system",
  "description": "FDA recall Z-0246-2026 — SEDECAL SA is recalling Model Number 40KWFXPLUS, Mobile X-ray 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": "Model Number 40KWFXPLUS, Mobile X-ray system",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0246-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0246-2026: SEDECAL SA is recalling Model Number 40KWFXPLUS, Mobile X-ray system",
      "text": "The FDA logged enforcement record Z-0246-2026: SEDECAL SA is voluntarily recalling Model Number 40KWFXPLUS, Mobile X-ray system — reason: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-10. Affected lots/codes: UDI/DI 08436046002166, Serial Numbers:  G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017, G80154, G73616, G73471, G76479, G79615, G80179, G79467, G79827, G79840, G79877, G79926, G78011, G78726, G82574, G82638, G73651, G75438, G77820, G78050, G79426, G79634, G82590, G72392, G73520, G73524, G73627, G73642, G73653, G76730, G76888, G78212, G78279, G78296, G78305, G78323, G82156, G83117, G83133, G73624, G82557, G84603, G84633, G84634, G84641, G84642, G84753, G84778, G84795, G84857, G84869, G84882, G84884, G84900, G84901, G84902, G84911, G84912, G85513, G85514, G85516, G85527, G85528, G79115, G79915, G72362, G75112, G75515, G79299, G79324, G73453, G79625, G77328, G75676, G75744, G75439, G78129, G78141, G76110, G76545, G78000, G80042, G73460, G75100, G75502, G84782, G79794, G83972, G84025, G79936, G84487, G75404, G73457, G75085, G79927, G75388, G73609, G76560, G78992, G82079, G82095, G84014, G75375, G75503, G75516, G73621, G73648, G72971, G77213, G79889, G77605, G79311, G75961, G77789, G84028, G73015, G73063, G78873, G79663, G79275, G73027, G76887, G79277, G79357, G76126, G75980, G76125, G76844, G77073, G77089, G77191, G77425, G73079, G75867, G83920, G84017, G77609, G77653, G84591, G75904, G75905, G73147, G73059, G77583, G77641, G77768, G77854, G77870, G77928, G84038, G72363, G73052, G75661, G75662, G75691, G84052, G72972, G73084, G73119, G76757, G76803, G84066, G77780, G73040, G73038, G73139, G75705, G76156, G76721, G84064, G79616, G82140, G82141, G82159, G83203, G75012, G79183, G79806, G70809, G79037, G79182, G80186, G76831, G77408, G79899, G82499, G75451, G75111, G73469, G82158, G80068, G84867, G75114, G75437, G77338, G76250, G77218, G77394, G79432, G79025, G83227, G79102, G79427, G77788, G75011, G75039, G83228, G79060, G78090, G80244, G80090, G82558, G76109, G72422, G75422, G76285, G77178, G78009, G78023, G78052, G78062, G78080, G78697, G78713, G78749, G78896, G79585, G79623, G82157, G83105, G83137, G77144, G75592, G76234, G76579, G78947, G77123, G82591, G78962, G79105, G80180, G79341, G79393, G84754, G76439, G75387, G73463, G73472, G79297, G80153.. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0246-2026&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0246-2026/fda-classification",
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      "name": "FDA classified recall Z-0246-2026 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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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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-0246-2026/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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      "grounding": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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            "Field": "Recalling firm",
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            "Field": "Distribution pattern",
            "Value": "US:  CA, IL, and NJ",
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