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  "name": "Med-Riser MR600 Patient Lift",
  "description": "FDA recall Z-1204-2023 — Med-Mizer, Inc. is recalling Med-Riser MR600 Patient Lift (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": "Med-Riser MR600 Patient Lift",
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      "name": "FDA recall Z-1204-2023: Med-Mizer, Inc. is recalling Med-Riser MR600 Patient Lift",
      "text": "The FDA logged enforcement record Z-1204-2023: Med-Mizer, Inc. is voluntarily recalling Med-Riser MR600 Patient Lift — reason: Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-03. Affected lots/codes: UDI-DI: 00852195007308; Serial No.: MR600000, MR600001, MR600002, MR600003, MR600004, MR600005, MR600006, MR600007, MR600008, MR600009, MR600010, MR600011, MR600012, MR600013, MR600014, MR600015, MR600016, MR600017, MR600018, MR600019, MR600020, MR600021, MR600022, MR600023, MR600024, MR600025, MR600026, MR600027, MR600028, MR600029, MR600030, MR600031, MR600032, MR600033, MR600034, MR600035, MR600036, MR600037, MR600038, MR600039, MR600040, MR600041, MR600042, MR600043, MR600044, MR600045, MR600046, MR600047, MR600048, MR600049, MR600050, MR600051, MR600052, MR600053, MR600054, MR600055, MR600056, MR600057, MR600058, MR600059, MR600060, MR600061, MR600062, MR600063, MR600064, MR600065, MR600066, MR600067, MR600068, MR600069, MR600070, MR600071, MR600072, MR600073, MR600074, MR600075, MR600076, MR600077, MR600078, MR600079, MR600080, MR600081, MR600082, MR600083, MR600084, MR600085, MR600086, MR600087, MR600088, MR600089, MR600090, MR600091, MR600092, MR600093, MR600094, MR600095, MR600096, MR600097, MR600098, MR600099, MR600100, MR600101, MR600102, MR600103, MR600104, MR600105, MR600106, MR600107, MR600108, MR600109, MR600110, MR600111, MR600112, MR600113, MR600114, MR600115, MR600116, MR600117, MR600118, MR600119, MR600120, MR600121, MR600122, MR600123, MR600124, MR600125, MR600126, MR600127, MR600128, MR600129, MR600130, MR600131, MR600132, MR600133, MR600134, MR600135, MR600136, MR600137, MR600138, MR600139, MR600140, MR600141, MR600142, MR600143, MR600144, MR600145, MR600146, MR600147, MR600148, MR600149, MR600150, MR600151, MR600152, MR600153, MR600154, MR600155, MR600156, MR600157, MR600158, MR600159, MR600160, MR600161, MR600162, MR600163, MR600164, MR600165, MR600166, MR600167, MR600168, MR600169, MR600170, MR600171, MR600172, MR600173, MR600174, MR600175, MR600176, MR600177, MR600178, MR600179, MR600180, MR600181, MR600182, MR600183, MR600184, MR600185, MR600186, MR600187, MR600188, MR600189, MR600190, MR600191, MR600192, MR600193, MR600194, MR600195, MR600196, MR600197, MR600198, MR600199, MR600200, MR600201, MR600202, MR600203, MR600204, MR600205, MR600206, MR600207, MR600208, MR600209, MR600210, MR600211, MR600212, MR600213, MR600214, MR600215, MR600216, MR600217, MR600218, MR600219, MR600220, MR600221, MR600222, MR600223, MR600224, MR600225, MR600226, MR600227, MR600228, MR600229, MR600230, MR600231, MR600232, MR600233, MR600234, MR600235, MR600236, MR600237, MR600238, MR600239, and MR600240.. A RECORDED FDA enforcement action (occurred=true).",
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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-1204-2023 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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      "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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      "@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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        "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
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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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            "Value": "Med-Mizer, Inc.",
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          "item": {
            "Field": "Reason",
            "Value": "Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.",
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            "Field": "Initiated",
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            "Value": "UDI-DI: 00852195007308; Serial No.: MR600000, MR600001, MR600002, MR600003, MR600004, MR600005, MR600006, MR600007, MR600008, MR600009, MR600010, MR600011, MR600012, MR600013, MR600014, MR600015, MR600016, MR600017, MR600018, MR600019, MR600020, MR600021, MR600022, MR600023, MR600024, MR600025, MR600026, MR600027, MR600028, MR600029, MR600030, MR600031, MR600032, MR600033, MR600034, MR600035, MR600036, MR600037, MR600038, MR600039, MR600040, MR600041, MR600042, MR600043, MR600044, MR600045, MR600046, MR600047, MR600048, MR600049, MR600050, MR600051, MR600052, MR600053, MR600054, MR600055, MR600056, MR600057, MR600058, MR600059, MR600060, MR600061, MR600062, MR600063, MR600064, MR600065, MR600066, MR600067, MR600068, MR600069, MR600070, MR600071, MR600072, MR600073, MR600074, MR600075, MR600076, MR600077, MR600078, MR600079, MR600080, MR600081, MR600082, MR600083, MR600084, MR600085, MR600086, MR600087, MR600088, MR600089, MR600090, MR600091, MR600092, MR600093, MR600094, MR600095, MR600096, MR600097, MR600098, MR600099, MR600100, MR600101, MR600102, MR600103, MR600104, MR600105, MR600106, MR600107, MR600108, MR600109, MR600110, MR600111, MR600112, MR600113, MR600114, MR600115, MR600116, MR600117, MR600118, MR600119, MR600120, MR600121, MR600122, MR600123, MR600124, MR600125, MR600126, MR600127, MR600128, MR600129, MR600130, MR600131, MR600132, MR600133, MR600134, MR600135, MR600136, MR600137, MR600138, MR600139, MR600140, MR600141, MR600142, MR600143, MR600144, MR600145, MR600146, MR600147, MR600148, MR600149, MR600150, MR600151, MR600152, MR600153, MR600154, MR600155, MR600156, MR600157, MR600158, MR600159, MR600160, MR600161, MR600162, MR600163, MR600164, MR600165, MR600166, MR600167, MR600168, MR600169, MR600170, MR600171, MR600172, MR600173, MR600174, MR600175, MR600176, MR600177, MR600178, MR600179, MR600180, MR600181, MR600182, MR600183, MR600184, MR600185, MR600186, MR600187, MR600188, MR600189, MR600190, MR600191, MR600192, MR600193, MR600194, MR600195, MR600196, MR600197, MR600198, MR600199, MR600200, MR600201, MR600202, MR600203, MR600204, MR600205, MR600206, MR600207, MR600208, MR600209, MR600210, MR600211, MR600212, MR600213, MR600214, MR600215, MR600216, MR600217, MR600218, MR600219, MR600220, MR600221, MR600222, MR600223, MR600224, MR600225, MR600226, MR600227, MR600228, MR600229, MR600230, MR600231, MR600232, MR600233, MR600234, MR600235, MR600236, MR600237, MR600238, MR600239, and MR600240.",
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