{
  "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": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 22
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "OUTPATIENT DIAGNOSTIC FACILITY",
      "report_to_fda": "Y",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "10612545",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20201001",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200916",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "report_date": "20200918",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20201001",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1081527",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20201001",
          "brand_name": "HORIZON W",
          "generic_name": "DENSITOMETER, BONE",
          "manufacturer_d_name": "HOLOGIC, INC.",
          "manufacturer_d_address_1": "250 CAMPUS DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MARLBOROUGH",
          "manufacturer_d_state": "MA",
          "manufacturer_d_zip_code": "01752",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "01752",
          "device_operator": "0",
          "model_number": "HORIZON W",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "KGI",
          "device_age_text": "6 MO",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Densitometer, Bone",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1170",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Therapeutic or Diagnostic Output Failure",
        "Noise, Audible"
      ],
      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20201001",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "23360 DA",
          "patient_sex": "",
          "patient_weight": "81",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Insufficient Information",
            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200918",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20201001",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10612545",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20200918",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "209398688",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DEXA MACHINE BEGAN MAKING A LOUD NOISE. THIS NOISE REMAINED AFTER TURNING OFF AND BACK ON. ATTEMPTED TO RUN A QUALITY CHECK, WHICH FAILED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}