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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2256-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:  (a) Symbia Pro.specta Q3, Model 11364751;  (b) Symbia Pro.specta X3, Model 11364752;  (c) Symbia Pro.specta X7, Model 11364753.",
  "description": "FDA recall Z-2256-2023 — Siemens Medical Solutions USA, Inc. is recalling The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:  (a) Symbia Pro.specta Q3, Model 11364751;  (b) Symbia Pro.specta X3, Model 11364752;  (c) Symbia Pro.specta X7, Model 11364753. (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-2256-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:  (a) Symbia Pro.specta Q3, Model 11364751;  (b) Symbia Pro.specta X3, Model 11364752;  (c) Symbia Pro.specta X7, Model 11364753.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Siemens Medical Solutions USA, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2256-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2256-2023: Siemens Medical Solutions USA, Inc. is recalling The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:  (a) Symbia Pro.specta Q3, Model 11364751;  (b) Symbia Pro.specta X3, Model 11364752;  (c) Symbia Pro.specta X7, Model 11364753.",
      "text": "The FDA logged enforcement record Z-2256-2023: Siemens Medical Solutions USA, Inc. is voluntarily recalling The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:  (a) Symbia Pro.specta Q3, Model 11364751;  (b) Symbia Pro.specta X3, Model 11364752;  (c) Symbia Pro.specta X7, Model 11364753. — reason: During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-07-12. Affected lots/codes: Software version VA20A.  (a) Serial numbers 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100209, 100208, 100210, 100212, 100211, 100213, 100215, 100217, 100219, 100218, 100220, 100221, and 100224; UDI-DI 4056869264745.  Additional serial numbers as of 09/07/2023: 100223, 100225, 100227, 100228, 100237; Additional serial numbers as of 10/17/2023: 100214, 100229; Additional serial numbers as of 12/12/2023:  100232, 100231, 100234; Additional serial number as of 01/15/2024:100226.   (b) Serial numbers 100101, 100102, 100201, 100203, 100204, 100207, 100206, 100208, 100205, 100209, 100210, 100212, 100213, 100214, 100215, 100216, 100218, 100217, 100219, 100220, 100221, 100223, 100224, 100222, 100226, 100228, 100227, 100225, 100229, 100231, 100232, 100233, 100235, 100234, 100237, 100239, 100241, 100240, 100236, 100238, 100242, 100243, 100247, 100244, 100250, 100251, 100252, and 100255; UDI-DI 4056869264752;  Additional serial numbers as of 09/07/2023: 100245, 100256, 100257, 100258, 100261, 100262, 100265, 100273; Additional serial numbers as of 10/17/2023: 100230, 100266; Additional serial numbers as of 12/12/2023:  100269; Additional serial numbers as of 01/15/2024: 100248, 100254, 100260, 100271, 100272.   (c) Serial numbers 100101, 100201, 100203, 100202, 100205, and 100206; UDI-DI 4056869264769; Additional serial numbers as of 09/07/2023: 100208, 100210; Additional serial numbers as of 12/12/2023:  100209. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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-2256-2023&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-2256-2023&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-2256-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2256-2023 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-2256-2023&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-2256-2023&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-2256-2023/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
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      "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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2256-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2256-2023",
            "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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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Siemens Medical Solutions USA, Inc.",
            "Status": "recorded"
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-07-12",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Software version VA20A.  (a) Serial numbers 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100209, 100208, 100210, 100212, 100211, 100213, 100215, 100217, 100219, 100218, 100220, 100221, and 100224; UDI-DI 4056869264745.  Additional serial numbers as of 09/07/2023: 100223, 100225, 100227, 100228, 100237; Additional serial numbers as of 10/17/2023: 100214, 100229; Additional serial numbers as of 12/12/2023:  100232, 100231, 100234; Additional serial number as of 01/15/2024:100226.   (b) Serial numbers 100101, 100102, 100201, 100203, 100204, 100207, 100206, 100208, 100205, 100209, 100210, 100212, 100213, 100214, 100215, 100216, 100218, 100217, 100219, 100220, 100221, 100223, 100224, 100222, 100226, 100228, 100227, 100225, 100229, 100231, 100232, 100233, 100235, 100234, 100237, 100239, 100241, 100240, 100236, 100238, 100242, 100243, 100247, 100244, 100250, 100251, 100252, and 100255; UDI-DI 4056869264752;  Additional serial numbers as of 09/07/2023: 100245, 100256, 100257, 100258, 100261, 100262, 100265, 100273; Additional serial numbers as of 10/17/2023: 100230, 100266; Additional serial numbers as of 12/12/2023:  100269; Additional serial numbers as of 01/15/2024: 100248, 100254, 100260, 100271, 100272.   (c) Serial numbers 100101, 100201, 100203, 100202, 100205, and 100206; UDI-DI 4056869264769; Additional serial numbers as of 09/07/2023: 100208, 100210; Additional serial numbers as of 12/12/2023:  100209",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution was made to ID, KS, MA, NH, OH, TX, and VA.  There was no government/military distribution.  Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
    }
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}