{
  "format": "devicerts.device.v1",
  "cite_as": "Radius VSM 4889, Masimo Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/radius-vsm-4889 (data as of 2026-11-15).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/radius-vsm-4889.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
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        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
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    "registry_records_last_synced": "2026-10-24",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/radius-vsm-4889",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Radius VSM 4889",
    "registry_name": "Radius VSM 4889",
    "url": "https://devicerts.com/devices/radius-vsm-4889",
    "manufacturer": {
      "name": "Masimo Corporation",
      "url": "https://devicerts.com/manufacturers/masimo-corporation",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
      "detail": "European Union and United States"
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    "classification": [
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            "value": "084399700000Y3T5A03V000J9",
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      {
        "label": "510(k) Number",
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          {
            "value": "K223498",
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          }
        ]
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    ],
    "product_codes": [
      "DXN",
      "MHX"
    ],
    "emdn": [
      {
        "code": "Z1203020202",
        "term": "TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS"
      }
    ],
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      {
        "code": "65834",
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    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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      "number": "Z-2670-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-02-20",
      "reason": "Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.",
      "applies": "shared submission",
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      "reason": "Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.",
      "applies": "shared submission",
      "via": "K223498"
    }
  ],
  "eu_market_availability": null,
  "properties": [
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          "label": "Trade name",
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            {
              "value": "Radius VSM NIBP Module",
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              "value": "Wearable multiple vital physiological parameter monitoring system",
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            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
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