{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149821",
      "product_res_number": "Z-0088-2017",
      "event_date_initiated": "2016-09-15",
      "event_date_posted": "2016-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-06-23",
      "res_event_number": "75257",
      "product_code": "LKD",
      "k_numbers": [
        "K041548",
        "K071672",
        "K101690",
        "K151329"
      ],
      "product_description": "SDMS (SenTec Digital Monitoring System)",
      "code_info": "SN 306497 to SN 306571.",
      "firm_fei_number": "3004149774",
      "recalling_firm": "SenTec AG",
      "address_1": "Ringstrasse 39 39 ringstrasse",
      "city": "Therwil",
      "country": "Switzerland",
      "additional_info_contact": "SenTec represenatative\n262-594-2114",
      "reason_for_recall": "Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain\ncircumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).",
      "root_cause_description": "Component change control",
      "action": "Distributors were sent via e-mail a SenTec 'Mandatory initiated field correction action\" letter dated September 15, 2016 .  The letter provided a \"Description of the issue, Affected products, Identify and  localize affected products, Removal from use, Replacement of affected products at end customer & distributor / sub-distributor level\".  It also provided \"action information for sub-distributors and affiliates, and end customers\".  For questions contact SenTec Inc. by e-mail (customersevice.usa@sentec.com) or phone (636-343-0000).",
      "product_quantity": "75 (54 US; 21 =OUS)",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.",
      "openfda": {
        "k_number": [
          "K990960",
          "K101690",
          "K891481",
          "K905225",
          "K093154",
          "K151329",
          "K232516",
          "K043003",
          "K041548",
          "K110474",
          "K900333",
          "K131253",
          "K913013",
          "K890517",
          "K043357",
          "K980756",
          "K883606"
        ],
        "pma_number": [
          "P800043",
          "P850087",
          "P810037",
          "P820019",
          "P830008",
          "P810022",
          "P840037",
          "P820025"
        ],
        "registration_number": [
          "3007490412",
          "3004149774",
          "3016618143",
          "3016701404",
          "9610816",
          "3013500228",
          "3013513377",
          "3000126629",
          "3012409105",
          "3009077524",
          "3012528160",
          "3002807968",
          "3013596024",
          "3003263092",
          "9614470",
          "8030885",
          "2020676",
          "3012866928"
        ],
        "fei_number": [
          "3007490412",
          "3004149774",
          "3016618143",
          "3016701404",
          "3013500228",
          "3013513377",
          "3000126629",
          "3012409105",
          "3009077524",
          "3012528160",
          "3002807167",
          "3002807968",
          "3013596024",
          "3003263092",
          "3002663379",
          "3003244961",
          "2020676",
          "3012866928"
        ],
        "device_name": "Monitor, Carbon-Dioxide, Cutaneous",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.2480",
        "device_class": "2"
      }
    }
  ]
}