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  "name": "Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table",
  "description": "FDA recall Z-0728-2024 — Oakworks Inc is recalling Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table (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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  "about": {
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    "name": "Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table",
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      "name": "Oakworks Inc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0728-2024/enforcement-record",
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      "name": "FDA recall Z-0728-2024: Oakworks Inc is recalling Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table",
      "text": "The FDA logged enforcement record Z-0728-2024: Oakworks Inc is voluntarily recalling Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table — reason: Backrest platform stress fracture - the table is not operational in an inclined position. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-05. Affected lots/codes: (UDI): , 00817463025439 S/N:  USW821950 USW821951 USM838906 USM838908 USM838909 USM838910 USM838911 USM838912 USW833604 USW803220 USW810646 USM802363 USM802364 USM802365 USM802366 USM802367 USM802368 USM802369 USM802370 USM802371 USM802372 USM802373 USM806418 USM806419 USM824495 USW824575 USW824576 USW835742 USW835743 USW835744 USW835745 USW835870 USW835871 USW805335 USW805500 USW814481 USW814489 USW814490 USW814491 USM818829 USM818830 USW834435 USW834436 USW834437 USW834438 USW837136 USW837137 USW837138 USW837139 USW837140 USM834172 USW825108 USW836285 USW825254 USW825255 USW825256 USM832158 USM837032 USM805639 USM805640 USW809784 USW809785 USW810360 USM810619 USW811819 USW825625 USW825626 USW833747 USW806381 USW809243 USW810505 USM814053 USM814054 USM814055 USW829084 USW838113 USW838114 USW807763 USW800305 USM812019 USM812024 USM820560 USW832338 USM827491 USM805539 USM813172 USM813173 USM806277 USW817676 USW817677 USW818075 USW829140 USM809220 USM809200 USM809202 USM797137 USM819374 USM819375 USM819376 USM819377 USM819378 USM819379 USM819381 USM819382. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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        "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-0728-2024 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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      "reviewStatus": "current",
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        "supported": true,
        "adjudged": true,
        "operative": true
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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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0728-2024/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",
        "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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