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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1206-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4.  For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.   CATALOG #(s):  8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F  8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F    Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).",
  "description": "FDA recall Z-1206-2023 — Carestream Health, Inc. is recalling DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4.  For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.   CATALOG #(s):  8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F  8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F    Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC). (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "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-1206-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4.  For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.   CATALOG #(s):  8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F  8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F    Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Carestream Health, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1206-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1206-2023: Carestream Health, Inc. is recalling DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4.  For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.   CATALOG #(s):  8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F  8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F    Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).",
      "text": "The FDA logged enforcement record Z-1206-2023: Carestream Health, Inc. is voluntarily recalling DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4.  For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.   CATALOG #(s):  8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F  8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F  8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F    Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC). — reason: After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement  unexpectedly to a certain distance which could potentially result in a injury. Status: Ongoing — the recall is still being carried out.. Initiated 2023-01-30. Affected lots/codes: UDI: 60889978621613 (Rayco) 60889978624188 (1049)  US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144  OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903 SP0600 SP1035 SP0930 SP1007 SP1037 SP0772 S0934G2 S0639G2 S1020G2 S0118 S0135 S0134 S0165 S0167 S0168 S0181 S0800G2 S0784G2 S0811G2 S0832G2 S0826G2 S0822G2 S1038G2 S0678G2 S0619G2 S0636G2 S0641G2 S0643G2 S0701G2 S0738G2 S0758G2 S0760G2 S0673G2 S0785G2 S0842G2 S0860G2 S0863G2 S0888G2 S0973G2 S1105G2 S1048G2 S1073G2 S1004G2 S1110G2 S0791G2 S0941G2  SP0900 S0625. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "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-1206-2023&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-1206-2023&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1206-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1206-2023 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1206-2023&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1206-2023&lang=eng"
        }
      },
      "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-1206-2023/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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      "name": "FDA recall details — Z-1206-2023",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1206-2023",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Carestream Health, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement  unexpectedly to a certain distance which could potentially result in a injury",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Initiated",
            "Value": "2023-01-30",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI: 60889978621613 (Rayco) 60889978624188 (1049)  US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144  OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903 SP0600 SP1035 SP0930 SP1007 SP1037 SP0772 S0934G2 S0639G2 S1020G2 S0118 S0135 S0134 S0165 S0167 S0168 S0181 S0800G2 S0784G2 S0811G2 S0832G2 S0826G2 S0822G2 S1038G2 S0678G2 S0619G2 S0636G2 S0641G2 S0643G2 S0701G2 S0738G2 S0758G2 S0760G2 S0673G2 S0785G2 S0842G2 S0860G2 S0863G2 S0888G2 S0973G2 S1105G2 S1048G2 S1073G2 S1004G2 S1110G2 S0791G2 S0941G2  SP0900 S0625",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.",
            "Status": "recorded"
          }
        }
      ]
    }
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}