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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1695-2025.jsonld",
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  "name": "Brand Name: Quantum Informatics - VIPER  Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)  Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.",
  "description": "FDA recall Z-1695-2025 — Spectrum Medical Ltd. is recalling Brand Name: Quantum Informatics - VIPER  Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)  Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events. (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": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1695-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Quantum Informatics - VIPER  Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)  Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Spectrum Medical Ltd."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1695-2025/enforcement-record",
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      "name": "FDA recall Z-1695-2025: Spectrum Medical Ltd. is recalling Brand Name: Quantum Informatics - VIPER  Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)  Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.",
      "text": "The FDA logged enforcement record Z-1695-2025: Spectrum Medical Ltd. is voluntarily recalling Brand Name: Quantum Informatics - VIPER  Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)  Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events. — reason: Medical device software marketed without FDA clearance .. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-19. Affected lots/codes: All software revisions/No UDI. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "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-1695-2025&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-1695-2025&lang=eng"
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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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      "name": "FDA classified recall Z-1695-2025 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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        "adjudged": true,
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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-1695-2025&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-1695-2025/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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      "grounding": {
        "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-1695-2025",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Spectrum Medical Ltd.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Medical device software marketed without FDA clearance .",
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            "Value": "California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentucky, New York, Kansas, South Carolina, Idaho, Tennessee, Oregon, Maine, Indiana, Oklahoma, New Mexico, North Dakota, Alabama, Michigan, Mississippi",
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