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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2663-2023.jsonld",
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  "name": "Veran : Percutaneous Always on Track  Models:  INS-5040\tAlways-On vTrack Universal Tracker, LG 7-12ga\t\t\t\t\t  INS-5039\tAlways-On vTrack Universal Tracker, SM/CL, 12-18ga\t\t\t\t\t  INS-5036\t\"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point\"\t\t\t\t\t  INS-5034\t17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t00815686020354  INS-5032\t\"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t  INS-5029\t\"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint\"\t\t\t\t\t  INS-5028\t19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point\t\t\t\t\t  INS-5024\t\"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t\t  INS-5023\t17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t  INS-5017\t17ga x 155mm Tip Tracked Bx Needle\t\t\t\t\t  INS-5016\t17ga x 155mm Tip Tracked Bx Needle",
  "description": "FDA recall Z-2663-2023 — Olympus Corporation of the Americas is recalling Veran : Percutaneous Always on Track  Models:  INS-5040\tAlways-On vTrack Universal Tracker, LG 7-12ga\t\t\t\t\t  INS-5039\tAlways-On vTrack Universal Tracker, SM/CL, 12-18ga\t\t\t\t\t  INS-5036\t\"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point\"\t\t\t\t\t  INS-5034\t17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t00815686020354  INS-5032\t\"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t  INS-5029\t\"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint\"\t\t\t\t\t  INS-5028\t19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point\t\t\t\t\t  INS-5024\t\"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t\t  INS-5023\t17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t  INS-5017\t17ga x 155mm Tip Tracked Bx Needle\t\t\t\t\t  INS-5016\t17ga x 155mm Tip Tracked Bx Needle (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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Veran : Percutaneous Always on Track  Models:  INS-5040\tAlways-On vTrack Universal Tracker, LG 7-12ga\t\t\t\t\t  INS-5039\tAlways-On vTrack Universal Tracker, SM/CL, 12-18ga\t\t\t\t\t  INS-5036\t\"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point\"\t\t\t\t\t  INS-5034\t17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t00815686020354  INS-5032\t\"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t  INS-5029\t\"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint\"\t\t\t\t\t  INS-5028\t19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point\t\t\t\t\t  INS-5024\t\"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t\t  INS-5023\t17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t  INS-5017\t17ga x 155mm Tip Tracked Bx Needle\t\t\t\t\t  INS-5016\t17ga x 155mm Tip Tracked Bx Needle",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2663-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2663-2023: Olympus Corporation of the Americas is recalling Veran : Percutaneous Always on Track  Models:  INS-5040\tAlways-On vTrack Universal Tracker, LG 7-12ga\t\t\t\t\t  INS-5039\tAlways-On vTrack Universal Tracker, SM/CL, 12-18ga\t\t\t\t\t  INS-5036\t\"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point\"\t\t\t\t\t  INS-5034\t17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t00815686020354  INS-5032\t\"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t  INS-5029\t\"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint\"\t\t\t\t\t  INS-5028\t19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point\t\t\t\t\t  INS-5024\t\"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t\t  INS-5023\t17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t  INS-5017\t17ga x 155mm Tip Tracked Bx Needle\t\t\t\t\t  INS-5016\t17ga x 155mm Tip Tracked Bx Needle",
      "text": "The FDA logged enforcement record Z-2663-2023: Olympus Corporation of the Americas is voluntarily recalling Veran : Percutaneous Always on Track  Models:  INS-5040\tAlways-On vTrack Universal Tracker, LG 7-12ga\t\t\t\t\t  INS-5039\tAlways-On vTrack Universal Tracker, SM/CL, 12-18ga\t\t\t\t\t  INS-5036\t\"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point\"\t\t\t\t\t  INS-5034\t17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t00815686020354  INS-5032\t\"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t  INS-5029\t\"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint\"\t\t\t\t\t  INS-5028\t19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point\t\t\t\t\t  INS-5024\t\"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t\t  INS-5023\t17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t  INS-5017\t17ga x 155mm Tip Tracked Bx Needle\t\t\t\t\t  INS-5016\t17ga x 155mm Tip Tracked Bx Needle — reason: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments)  manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-10. Affected lots/codes: Model-UDI: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga  00815686020705; INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga     00815686020699; INS-5036 \"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point\"   00815686020361; INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point     00815686020354; INS-5032 \"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"     00815686020330; INS-5029 \"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point\"     00815686020309; INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point     00815686020293; INS-5024 \"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"     00815686020255; INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point     00815686020248; INS-5017 17ga x 155mm Tip Tracked Bx Needle   00815686020224; INS-5016 17ga x 155mm Tip Tracked Bx Needle   00815686020217;   All serial numbers and all lot numbers. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-2663-2023&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-2663-2023&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-2663-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2663-2023 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-2663-2023&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-2663-2023&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-2663-2023/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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2663-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2663-2023",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Olympus Corporation of the Americas",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments)  manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment",
            "Status": "recorded"
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2023-08-10",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model-UDI: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga  00815686020705; INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga     00815686020699; INS-5036 \"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point\"   00815686020361; INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point     00815686020354; INS-5032 \"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"     00815686020330; INS-5029 \"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point\"     00815686020309; INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point     00815686020293; INS-5024 \"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"     00815686020255; INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point     00815686020248; INS-5017 17ga x 155mm Tip Tracked Bx Needle   00815686020224; INS-5016 17ga x 155mm Tip Tracked Bx Needle   00815686020217;   All serial numbers and all lot numbers",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.",
            "Status": "recorded"
          }
        }
      ]
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}