{
  "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": "Taastrup",
      "state": "",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83380",
      "recalling_firm": "GN Otometrics",
      "address_1": "Horskatten 9",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI,  and WV  Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Czech Republic, Denmark, Ecuador, Egypt,  El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guyana, Hong Kong, Hungary, India,   Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Malaysia, Maldives, Mayotte, Mexico, Morocco, Morocco, Netherlands, Netherlands, New Zealand, Norway,  Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia,   Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom,   Viet Nam, and Zimbabwe",
      "recall_number": "Z-0170-2020",
      "product_description": "The ICS CHARTR EP 200",
      "product_quantity": "3071 individual units",
      "reason_for_recall": "There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.",
      "recall_initiation_date": "20190528",
      "center_classification_date": "20191023",
      "termination_date": "20210409",
      "report_date": "20191030",
      "code_info": "Part No.               Description                                      UDI of the Device  8-04-12733 ICS Chartr EP 200 2Ch, TDH49 , 115/60 05713315006449;   8-04-12734 ICS Chartr EP 200 2Ch,Insert&Bone         05713315006173;   8-04-12731 ICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone; TDH49 Earhone w cable, Bone Conduction Transducer (B71),  VEMP Monitor Kit and ASSR                                                                         05713315006432;   8-04-12730 ICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone; TDH49 Earhone w cable, Bone Conduction Transducer (B71) and ASSR                                                                                                  05713315006425; 8-04-12729 ICS Chartr EP 200 2Ch, 230 VAC (50 Hz) Incl. Insert Earphone,  Bone Conduction Transducer (B71) and VEMP Monitor Kit 05713315006388;    8-04-12727 ICS Chartr EP 200 2Ch, 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable and VEMP Monitor Kit                 05713315006418;  8-04-12725 ICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable, Bone Conduction Transducer (B71), VEMP Monitor Kit, P300 and ASSR                                                        05713315006395;   8-04-12723 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable                                                        05713315006401;  8-04-12721 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone                                                                                                  05713315006371;  8-04-12720 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable, Bone Conduction Transducer (B71) and EU power cord.                                                                                 05713315007996;  8-04-12711 1073 ICS Chartr EP 200 w/o Vemp, CN only  N/A;  8-04-12710 1073 ICS Chartr EP 200, CN only                  N/A;  8-04-12703 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only                                                                                        05713315002724;  8-04-12702 1073 ICS Chartr EP 200 Insert, Bone 2 Ch, US only                                                                                       05713315002717;  8-04-12701 1073 ICS Chartr EP 200 ROW 2 Ch.       N/A;  8-04-12700 1073 ICS Chartr EP 200 Insert 2 Ch, US Only 05713315002700;  8-04-12732 ICS Chartr EP 200 Limited, 1 ch, TDH49, 115/60                                                                                  05713315006364;  8-04-12728 ICS Chartr EP 200 Limited, 1 ch Insert, Bone, TDH49 & VEMP Monitor Kit                                                                      05713315006333;  8-04-12726 ICS Chartr EP 200 Limited, 1 ch, TDH49     05713315006357;  8-04-12724 ICS Chartr EP 200 Limited, 1 ch Insert & TDH49                                                                                  05713315006340;   8-04-12722 ICS Chartr EP 200 Limited, 1 ch, Insert       05713315006326;  8-04-12712 1073 Chartr EP 200 Limited, China                N/A; and   8-04-12704 1073 Chartr EP 200 Limited                       05713315003226",
      "more_code_info": ""
    }
  ]
}