{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "170734",
      "product_res_number": "Z-1101-2019",
      "event_date_initiated": "2018-12-31",
      "event_date_created": "2019-04-22",
      "recall_status": "Open, Classified",
      "res_event_number": "82045",
      "product_code": "OAS",
      "k_numbers": [
        "K170813",
        "K180947"
      ],
      "product_description": "cone-beam CT system",
      "code_info": "versions 2.1.0 and 2.1.1",
      "firm_fei_number": "1017522",
      "recalling_firm": "KaVo Dental Technologies LLC",
      "address_1": "11727 Fruehauf Dr",
      "city": "Charlotte",
      "state": "NC",
      "postal_code": "28273-6507",
      "additional_info_contact": "704-588-2126",
      "reason_for_recall": "ORTHOPANTOMOGRAPH OP 3D device has a\ndefect in the device firmware versions 2.1.0 and 2.1.1",
      "root_cause_description": "Device Design",
      "action": "Palodex Group Oy  sent a Notification letter to affected customers on or about December 31, 2018.   The letter identified the affected product, problem and actions to be taken.  The firm corrective action is to update the firmware of ORTHOPANTOMOGRAPH OP 3D of the defective units.  Acknowledgement to the field correction letter is requested within 30 days from receiving the letter.",
      "product_quantity": "230",
      "distribution_pattern": "US distribution in NC",
      "openfda": {
        "k_number": [
          "K252353",
          "K260462",
          "K260093",
          "K122018",
          "K181983",
          "K181452",
          "K152106",
          "K103711",
          "K193329",
          "K130432",
          "K200271",
          "K120753",
          "K063622",
          "K190320",
          "K190496",
          "K130442",
          "K220392",
          "K160882",
          "K214084",
          "K212254",
          "K130297",
          "K200270",
          "K063773",
          "K162085",
          "K132983",
          "K253935",
          "K161900",
          "K151612",
          "K180601",
          "K232287",
          "K142247",
          "K122606",
          "K201627",
          "K180918",
          "K250839",
          "K192737",
          "K121236",
          "K240855",
          "K251642",
          "K150217",
          "K160166",
          "K150354",
          "K090467",
          "K182614",
          "K181576",
          "K253959",
          "K170813",
          "K230505",
          "K121412",
          "K221525",
          "K152489",
          "K230753",
          "K090171",
          "K102196",
          "K122981",
          "K120948",
          "K181136",
          "K232166",
          "K201382",
          "K123070",
          "K103659",
          "K200688",
          "K191616",
          "K212303",
          "K261748",
          "K242805",
          "K133544",
          "K232487",
          "K151137",
          "K110839",
          "K160140",
          "K250060",
          "K243081",
          "K131695",
          "K170066",
          "K251842",
          "K190856",
          "K083917",
          "K121400",
          "K203784",
          "K231796",
          "K122199",
          "K223794",
          "K101181",
          "K082410",
          "K180947",
          "K110260",
          "K200183",
          "K143435",
          "K213579",
          "K161881",
          "K162660",
          "K223816",
          "K041137",
          "K231181",
          "K213226",
          "K082350",
          "K193139",
          "K201378",
          "K201140",
          "K222666",
          "K133797",
          "K201667",
          "K210329",
          "K123381",
          "K182805",
          "K181432",
          "K003787",
          "K251798",
          "K241249",
          "K200469",
          "K190812",
          "K243337",
          "K232710",
          "K173878",
          "K183475",
          "K233806",
          "K123332",
          "K171012",
          "K130443",
          "K211159",
          "K133620",
          "K243088",
          "K163423",
          "K243903",
          "K260662",
          "K210820",
          "K230985",
          "K133406",
          "K222150",
          "K222219",
          "K213278",
          "K160525",
          "K203797",
          "K160506"
        ],
        "registration_number": [
          "3018596740",
          "3007538876",
          "3009196578",
          "3045816948",
          "3005706667",
          "3021551875",
          "3008770655",
          "3003528079",
          "3010445368",
          "3012494290",
          "3002994636",
          "9614977",
          "3005383085",
          "3004884150",
          "3009717300",
          "3010281549",
          "8020825",
          "3015509619",
          "2024980",
          "3005843418",
          "3005554774",
          "3035879459",
          "3013511605",
          "1226003",
          "3006610845",
          "3009543051",
          "3012957335",
          "3011471624",
          "3002819275",
          "3001052305",
          "8043728",
          "3031093388",
          "3004706313",
          "3009715136",
          "3023322470",
          "3016875543",
          "3012649815",
          "3018999255",
          "3045129740",
          "9615832",
          "3002807636",
          "3030089804",
          "3017403245",
          "8030876",
          "3014398772",
          "3014980469",
          "3031886796",
          "3030898585"
        ],
        "fei_number": [
          "3018596740",
          "3007538876",
          "3009196578",
          "3045816948",
          "3005706667",
          "3021551875",
          "3008770655",
          "3003528079",
          "3010445368",
          "3012494290",
          "3002994636",
          "3008875470",
          "3005383085",
          "3002807903",
          "3004884150",
          "7695",
          "3009717300",
          "3010281549",
          "3003719498",
          "3015509619",
          "3005843418",
          "3005554774",
          "3035879459",
          "3013511605",
          "3006610845",
          "3009543051",
          "3012957335",
          "3011471624",
          "3002819275",
          "3001052305",
          "1000207287",
          "3002522649",
          "3031093388",
          "3004706313",
          "3009715136",
          "3023322470",
          "3016875543",
          "3012649815",
          "3018999255",
          "3045129740",
          "3030089804",
          "3002807636",
          "3017403245",
          "3014398772",
          "3014980469",
          "3031886796",
          "3030898585",
          "3003026827"
        ],
        "device_name": "X-Ray, Tomography, Computed, Dental",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1750",
        "device_class": "2"
      }
    }
  ]
}