{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 922
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "2126677-2008-00013",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080222",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K802047",
      "date_of_event": "20080123",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20130211",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080222",
          "brand_name": "AMX 4",
          "generic_name": "",
          "manufacturer_d_name": "GE MEDICAL SYSTEMS, LLC",
          "manufacturer_d_address_1": "3000 N GRANDVIEW BLVD.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "WAUKESHA",
          "manufacturer_d_state": "WI",
          "manufacturer_d_zip_code": "53188",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "53188",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "46-270615P1",
          "catalog_number": "NA",
          "lot_number": "NA",
          "other_id_number": "NA",
          "device_availability": "Yes",
          "device_report_product_code": "IZL",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "2126677"
            ],
            "fei_number": [
              "2126677"
            ],
            "device_name": "System, X-Ray, Mobile",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1720",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Loose or Intermittent Connection"
      ],
      "reporter_state_code": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "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": "20080222",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080123",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1001251",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080123",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "20897441",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE COLLIMATOR WAS LOOSE. THERE WAS NEITHER INJURY REPORTED NOR PATIENT INVOLVEMENT. THE CONCERN WAS FOR A SERIOUS INJURY IF THE COLLIMATOR WERE TO FALL ON A PATIENT OR AN OPERATOR."
        },
        {
          "mdr_text_key": "21184615",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT ONE SCREW WAS HOLDING THE COLLIMATOR WHILE THE REST OF THE SCREWS WERE MISSING. THE FE INSTALLED NEW SCREWS AND RETURNED THE PRODUCT BACK TO SERVICE. PROPER PREVENTIVE MAINTENANCE IS CURRENTLY IN PLACE PER THE GE PREVENTATIVE MAINTENANCE TO DETECT THIS TYPE OF ISSUE."
        }
      ],
      "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": ""
    }
  ]
}