{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Boulder",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98407",
      "recalling_firm": "Covidien LLC",
      "address_1": "6135 Gunbarrel Ave",
      "address_2": "N/A",
      "postal_code": "80301-3214",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-1557-2026",
      "product_description": "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).",
      "product_quantity": "78 systems",
      "reason_for_recall": "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.",
      "recall_initiation_date": "20260130",
      "center_classification_date": "20260311",
      "report_date": "20260318",
      "code_info": "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"
    }
  ]
}