{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Therwil",
      "state": "N/A",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87054",
      "recalling_firm": "SenTec AG",
      "address_1": "Ringstrasse 39",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "IL, PA, FL, NJ, GA, MA",
      "recall_number": "Z-1134-2021",
      "product_description": "SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).",
      "product_quantity": "15 devices",
      "reason_for_recall": "Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.",
      "recall_initiation_date": "20201210",
      "center_classification_date": "20210218",
      "report_date": "20210224",
      "code_info": "Serial Numbers:  303170, 311263, 311166, 311408, 303426*  *serial number information current as of today's date"
    }
  ]
}