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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1925-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)  Product Name: OBM00002 OBM DAB (Digital Acquisition Box)  Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)  Software Version: N/A  Product Description: OBM00002 OBM DAB (Digital Acquisition Box)  Component: No",
  "description": "FDA recall Z-1925-2025 — Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)  Product Name: OBM00002 OBM DAB (Digital Acquisition Box)  Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)  Software Version: N/A  Product Description: OBM00002 OBM DAB (Digital Acquisition Box)  Component: No (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/",
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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-1925-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)  Product Name: OBM00002 OBM DAB (Digital Acquisition Box)  Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)  Software Version: N/A  Product Description: OBM00002 OBM DAB (Digital Acquisition Box)  Component: No",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Natus Neurology DBA Excel Tech., Ltd. (XLTEK)"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1925-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1925-2025: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)  Product Name: OBM00002 OBM DAB (Digital Acquisition Box)  Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)  Software Version: N/A  Product Description: OBM00002 OBM DAB (Digital Acquisition Box)  Component: No",
      "text": "The FDA logged enforcement record Z-1925-2025: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is voluntarily recalling Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)  Product Name: OBM00002 OBM DAB (Digital Acquisition Box)  Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)  Software Version: N/A  Product Description: OBM00002 OBM DAB (Digital Acquisition Box)  Component: No — reason: Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-07. Affected lots/codes: UDI-DI 00382830010825  Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of \"OBM\". A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-1925-2025&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-1925-2025&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1925-2025/fda-classification",
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      "name": "FDA classified recall Z-1925-2025 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": {
          "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-1925-2025&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-1925-2025/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": {
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        "groundingType": "Interpretation",
        "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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      "name": "FDA recall details — Z-1925-2025",
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            "Value": "Z-1925-2025",
            "Status": "recorded"
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            "Field": "Classification",
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          "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": "Natus Neurology DBA Excel Tech., Ltd. (XLTEK)",
            "Status": "recorded"
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          "position": 6,
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            "Field": "Reason",
            "Value": "Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.",
            "Status": "recorded"
          }
        },
        {
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            "Field": "Initiated",
            "Value": "2025-05-07",
            "Status": "recorded"
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            "Value": "UDI-DI 00382830010825  Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of \"OBM\"",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH), Chile (CL), Colombia (CO), Netherlands (the) (NL), Japan (JP), United Kingdom of Great Britain and Northern Ireland(the) (GB), Russian Federation (the)(RU), Bolivia (Plurinational State of) (BO), Canada (CA), France (FR), Peru (PE), Guyana (GY), Mexico (MX), Belgium (BE), Thailand (TH), Paraguay (PY), Hong Kong (HK), United Arab Emirates (AE), Austria (AT), India (IN), Indonesia (ID), Kuwait (KW), Qatar (QA), Lithuania (LT), Denmark (DK), Myanmar (MM), Uruguay (UY), Tunisia (TN), Turkey (TR), Korea (the Republic of) (KR), Hungary (HU), Slovenia (SI), Argentina (AR), Norway (NO), Oman (OM), Poland (PL), Finland (FI), Ireland (IE), Australia (AU), Latvia (LV), Ecuador (EC), Singapore (SG), Spain (ES), Serbia (RS), South Africa (ZA), Romania (RO), Algeria (DZ), Portugal (PT), Dominican Republic (the) (DO), Lebanon (LB), Malaysia (MY), Costa Rica (CR), Viet Nam (VN), & Bahrain (BH).",
            "Status": "recorded"
          }
        }
      ]
    }
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}