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  "name": "OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck  Model Number: NL5000",
  "description": "FDA recall Z-2068-2023 — NeuroLogica Corporation is recalling OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck  Model Number: NL5000 (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": "OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck  Model Number: NL5000",
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      "name": "FDA recall Z-2068-2023: NeuroLogica Corporation is recalling OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck  Model Number: NL5000",
      "text": "The FDA logged enforcement record Z-2068-2023: NeuroLogica Corporation is voluntarily recalling OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck  Model Number: NL5000 — reason: 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment.  2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-06. Affected lots/codes: GTIN:  10815411020335  10815411020663  Serial Numbers: 10 14 23 25 26 36 38 40 41 42 44 46 48 49 50 51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 15R. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2068-2023/fda-classification",
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      "name": "FDA classified recall Z-2068-2023 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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      "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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2068-2023/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.",
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        "adjudicator": null
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      "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": "1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment.  2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment",
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            "Value": "GTIN:  10815411020335  10815411020663  Serial Numbers: 10 14 23 25 26 36 38 40 41 42 44 46 48 49 50 51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 15R",
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