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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1557-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:  Product Number:  VSLBASE03P / VITALSYNCSW03  Model / UDI-DI codes:  Vital Sync 3.3.1 / 10884521844933  Vital Sync 3.4.0 / 10884521844940  Vital Sync 3.4.1 / 10884521847569 (OUS Only)  Vital Sync 3.4.2 / 10884521856127    Product Number:  VSLBASE04P / VITALSYNCSW04  Model / UDI-DI codes:  Vital Sync 4.0.0 / 10884521849358  Vital Sync 4.0.2 / 10884521856134    The Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).",
  "description": "FDA recall Z-1557-2026 — Covidien LLC is recalling HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:  Product Number:  VSLBASE03P / VITALSYNCSW03  Model / UDI-DI codes:  Vital Sync 3.3.1 / 10884521844933  Vital Sync 3.4.0 / 10884521844940  Vital Sync 3.4.1 / 10884521847569 (OUS Only)  Vital Sync 3.4.2 / 10884521856127    Product Number:  VSLBASE04P / VITALSYNCSW04  Model / UDI-DI codes:  Vital Sync 4.0.0 / 10884521849358  Vital Sync 4.0.2 / 10884521856134    The Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1557-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:  Product Number:  VSLBASE03P / VITALSYNCSW03  Model / UDI-DI codes:  Vital Sync 3.3.1 / 10884521844933  Vital Sync 3.4.0 / 10884521844940  Vital Sync 3.4.1 / 10884521847569 (OUS Only)  Vital Sync 3.4.2 / 10884521856127    Product Number:  VSLBASE04P / VITALSYNCSW04  Model / UDI-DI codes:  Vital Sync 4.0.0 / 10884521849358  Vital Sync 4.0.2 / 10884521856134    The Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Covidien LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1557-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1557-2026: Covidien LLC is recalling HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:  Product Number:  VSLBASE03P / VITALSYNCSW03  Model / UDI-DI codes:  Vital Sync 3.3.1 / 10884521844933  Vital Sync 3.4.0 / 10884521844940  Vital Sync 3.4.1 / 10884521847569 (OUS Only)  Vital Sync 3.4.2 / 10884521856127    Product Number:  VSLBASE04P / VITALSYNCSW04  Model / UDI-DI codes:  Vital Sync 4.0.0 / 10884521849358  Vital Sync 4.0.2 / 10884521856134    The Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).",
      "text": "The FDA logged enforcement record Z-1557-2026: Covidien LLC is voluntarily recalling HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:  Product Number:  VSLBASE03P / VITALSYNCSW03  Model / UDI-DI codes:  Vital Sync 3.3.1 / 10884521844933  Vital Sync 3.4.0 / 10884521844940  Vital Sync 3.4.1 / 10884521847569 (OUS Only)  Vital Sync 3.4.2 / 10884521856127    Product Number:  VSLBASE04P / VITALSYNCSW04  Model / UDI-DI codes:  Vital Sync 4.0.0 / 10884521849358  Vital Sync 4.0.2 / 10884521856134    The Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). — reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-30. Affected lots/codes: HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of: CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933 Serial Number: Vital Sync 3.3.1  CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521844940 Serial Number: Vital Sync 3.4.0  CFN: VSLBASE03P / VITALSYNCSW03 (OUS only) UDI-DI (GTIN): 10884521847569 Serial Number: Vital Sync 3.4.1  CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521856127 Serial Number: Vital Sync 3.4.2  CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521849358 Serial Number: Vital Sync 4.0.1  CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521856134 Serial Number:  Vital Sync 4.0.2. A RECORDED FDA enforcement action (occurred=true).",
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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-1557-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1557-2026&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1557-2026/fda-classification",
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      "name": "FDA classified recall Z-1557-2026 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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        "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-1557-2026&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-1557-2026/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",
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        "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-1557-2026",
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            "Value": "Z-1557-2026",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Covidien LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
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          "item": {
            "Field": "Initiated",
            "Value": "2026-01-30",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of: CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933 Serial Number: Vital Sync 3.3.1  CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521844940 Serial Number: Vital Sync 3.4.0  CFN: VSLBASE03P / VITALSYNCSW03 (OUS only) UDI-DI (GTIN): 10884521847569 Serial Number: Vital Sync 3.4.1  CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521856127 Serial Number: Vital Sync 3.4.2  CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521849358 Serial Number: Vital Sync 4.0.1  CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521856134 Serial Number:  Vital Sync 4.0.2",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.",
            "Status": "recorded"
          }
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}