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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0223-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Shanghai United Imaging Healthcare Co., Ltd.   Positron Emission Tomography and Computed Tomography System  Model:uMI 550  MD, Rx Only",
  "description": "FDA recall Z-0223-2026 — UIH Technologies LLC is recalling Shanghai United Imaging Healthcare Co., Ltd.   Positron Emission Tomography and Computed Tomography System  Model:uMI 550  MD, Rx Only (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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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0223-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Shanghai United Imaging Healthcare Co., Ltd.   Positron Emission Tomography and Computed Tomography System  Model:uMI 550  MD, Rx Only",
    "manufacturer": {
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      "name": "UIH Technologies LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0223-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0223-2026: UIH Technologies LLC is recalling Shanghai United Imaging Healthcare Co., Ltd.   Positron Emission Tomography and Computed Tomography System  Model:uMI 550  MD, Rx Only",
      "text": "The FDA logged enforcement record Z-0223-2026: UIH Technologies LLC is voluntarily recalling Shanghai United Imaging Healthcare Co., Ltd.   Positron Emission Tomography and Computed Tomography System  Model:uMI 550  MD, Rx Only — reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-12. Affected lots/codes: UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010. 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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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0223-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0223-2026&lang=eng"
        }
      },
      "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-0223-2026/fda-classification",
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      "name": "FDA classified recall Z-0223-2026 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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        "adjudged": true,
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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-0223-2026/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",
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      "epistemicStatus": {
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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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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Reason",
            "Value": "Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.",
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            "Field": "Initiated",
            "Value": "2025-09-12",
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            "Field": "Lot/code info",
            "Value": "UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010",
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