{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1623-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "NIM Vital Nerve Monitoring System:  CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;\t\t  CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;\t\t  PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;\t\t  PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;\t\t  SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;\t\t  SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;\t\t  SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164",
  "description": "FDA recall Z-1623-2025 — Medtronic Xomed, Inc. is recalling NIM Vital Nerve Monitoring System:  CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;\t\t  CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;\t\t  PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;\t\t  PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;\t\t  SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;\t\t  SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;\t\t  SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164 (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1623-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "NIM Vital Nerve Monitoring System:  CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;\t\t  CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;\t\t  PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;\t\t  PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;\t\t  SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;\t\t  SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;\t\t  SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic Xomed, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1623-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1623-2025: Medtronic Xomed, Inc. is recalling NIM Vital Nerve Monitoring System:  CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;\t\t  CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;\t\t  PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;\t\t  PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;\t\t  SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;\t\t  SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;\t\t  SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164",
      "text": "The FDA logged enforcement record Z-1623-2025: Medtronic Xomed, Inc. is voluntarily recalling NIM Vital Nerve Monitoring System:  CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;\t\t  CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;\t\t  PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;\t\t  PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;\t\t  SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;\t\t  SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;\t\t  SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164 — reason: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-10. Affected lots/codes: All NIM Vital Nerve Monitoring Systems manufactured or installed with software version v1.6.4 or earlier.  REF/UDI-DI: NIM4CM01/763000002978, 00763000395896, 00763000401597, 00763000528577; NIM4CM01RF/00763000002992; NIM4CPB1/763000002985, 00763000401603, 00763000395902, 00763000528584; NIM4CPB1RF/00763000003005; NIM4SWU143/00763000709341, 00763000869823; NIM4SWU154/00763000945398; NIM4SWU164/00763000974312. 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-1623-2025&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-1623-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1623-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1623-2025 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-1623-2025&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-1623-2025&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-1623-2025/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": {
        "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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1623-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1623-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "Medtronic Xomed, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-03-10",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All NIM Vital Nerve Monitoring Systems manufactured or installed with software version v1.6.4 or earlier.  REF/UDI-DI: NIM4CM01/763000002978, 00763000395896, 00763000401597, 00763000528577; NIM4CM01RF/00763000002992; NIM4CPB1/763000002985, 00763000401603, 00763000395902, 00763000528584; NIM4CPB1RF/00763000003005; NIM4SWU143/00763000709341, 00763000869823; NIM4SWU154/00763000945398; NIM4SWU164/00763000974312",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}