{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "4106 Therwil",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70878",
      "recalling_firm": "SenTec AG",
      "address_1": "Ringstrasse 39",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Distribution to the state of : MO",
      "recall_number": "Z-1501-2015",
      "product_description": "Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland.  The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2),  and pulse rate (PR).",
      "product_quantity": "129 US, 59 OUS",
      "reason_for_recall": "SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring.  This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement.  There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens",
      "recall_initiation_date": "20150325",
      "center_classification_date": "20150422",
      "termination_date": "20160205",
      "report_date": "20150429",
      "code_info": "315.105   315.106  315.107   315.108   315.109   315.111   315.112   315.113   315.114   315.115   315.116   315.117   315.118   315.119   315.120   315.122   315.123   315.124   315.125   315.126    315.127   315.128   315.285   315.286   315.287   315.288   315.289   315.290   315.291   315.292   315.294   315.295   315.296   315.297   315.298   315.299   315.300   315.301   315.302   315.303   315.305   315.306   315.307   315.308   315.309   315.310   315.311   315.312  315.313   315.314   315.275   315.276   315.277  315.278  315.279   315.280   315.281   315.282   315.283   315.284   315.597   315.599     315.600   315.601  315.602   315.603   315.604   315.605   315.606   315.607   315.610   315.611   315.561   315.562   315.563   315.564  315.565  315.566   315.567   315.568   315.569   315.571   315.572   315.573  315.574     Expanded:    314.804  314.813  314.815  314.820  315.414  315.415  315.416  315.417  315.418  315.419  315.420  315.421  315.422  315.423  315.424  315.425  315.426  315.427  315.428  315.429  315.430  315.431  315.432  315.433  315.434  315.435  315.436  315.437  315.438  315.439  315.440  315.441  315.442  315.443  315.445  315.446  315.447  315.448  315.449  315.450  315.452  315.453  315.454  315.455  315.456  315.457  315.458  315.459",
      "more_code_info": ""
    }
  ]
}