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  "name": "Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.    The affected power supplies are related to the following Tempus Pro Patient Monitoring units:    Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R  Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R",
  "description": "FDA recall Z-1321-2023 — Remote Diagnostic Technologies Ltd. is recalling Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.    The affected power supplies are related to the following Tempus Pro Patient Monitoring units:    Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R  Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1321-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.    The affected power supplies are related to the following Tempus Pro Patient Monitoring units:    Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R  Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Remote Diagnostic Technologies Ltd."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1321-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1321-2023: Remote Diagnostic Technologies Ltd. is recalling Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.    The affected power supplies are related to the following Tempus Pro Patient Monitoring units:    Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R  Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R",
      "text": "The FDA logged enforcement record Z-1321-2023: Remote Diagnostic Technologies Ltd. is voluntarily recalling Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.    The affected power supplies are related to the following Tempus Pro Patient Monitoring units:    Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R  Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R — reason: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-23. Affected lots/codes: Model Numbers: 00-1004 00-1004-R UDI-DI Codes: 05060472440020 05060472442901  00-1007 00-1007-R UDI-DI Codes: 05060472440013 05060472442901  00-1024-R UDI-DI Codes: 05060472441027 05060472442925  00-1026-R UDI-DI Codes: 05060472441058 05060472442932  Lot Codes - All products manufactured are affected.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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        "groundingType": "SourceCitation",
        "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-1321-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1321-2023&lang=eng"
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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-1321-2023 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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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
        "adjudicator": {
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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.",
      "claimType": "interpretation",
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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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  ],
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      "name": "FDA recall details — Z-1321-2023",
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            "Value": "Z-1321-2023",
            "Status": "recorded"
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            "Field": "Classification",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Value": "Remote Diagnostic Technologies Ltd.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.",
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            "Field": "Initiated",
            "Value": "2023-02-23",
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            "Field": "Lot/code info",
            "Value": "Model Numbers: 00-1004 00-1004-R UDI-DI Codes: 05060472440020 05060472442901  00-1007 00-1007-R UDI-DI Codes: 05060472440013 05060472442901  00-1024-R UDI-DI Codes: 05060472441027 05060472442925  00-1026-R UDI-DI Codes: 05060472441058 05060472442932  Lot Codes - All products manufactured are affected.",
            "Status": "recorded"
          }
        },
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei Darussalam, Bolivia, Canada, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Cayman Islands, Luxembourg, Malaysia, Netherlands, Norway, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Mayotte, and South Africa.",
            "Status": "recorded"
          }
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