{
  "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": "Terminated",
      "city": "Bronshoj",
      "state": "N/A",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85257",
      "recalling_firm": "Radiometer Medical ApS",
      "address_1": "Akandevej 21",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including the states of FL, KS, NY, ND, IN, TX, CA , VA, MA, MN, WI, IN, CT, WA and the countries of China, India, Japan, south Korea.",
      "recall_number": "Z-1755-2020",
      "product_description": "TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.",
      "product_quantity": "84 units",
      "reason_for_recall": "Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.",
      "recall_initiation_date": "20200220",
      "center_classification_date": "20200422",
      "termination_date": "20220624",
      "report_date": "20200429",
      "code_info": "Affected Serial Numbers:    391-880R0471N017, 391-880R0471N030, 391-880R0473N006, 391-880R0473N016,  391-880R0471N021, 391-880R0472N010, 391-880R0473N007,   391-880R0471N022, 391-880R0472N011, 391-880R0473N008,   391-880R0471N023, 391-880R0472N014, 391-880R0473N009,   391-880R0471N024, 391-880R0472N016, 391-880R0473N010,   391-880R0471N025, 391-880R0472N020, 391-880R0473N011,   391-880R0471N026, 391-880R0473N001, 391-880R0473N020,   391-880R0471N027, 391-880R0473N002, 391-880R0473N013,   391-880R0471N028, 391-880R0473N003, 391-880R0473N014,   391-880R0471N029, 391-880R0473N005, 391-880R0473N015,"
    }
  ]
}