{ "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": "2026-06-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "NO INFORMATION", "report_to_fda": "I", "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": "MW5098869", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20210115", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20201218", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20210119", "manufacturer_contact_f_name": "", "previous_use_code": "N", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "78898", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20210115", "brand_name": "QUANTX", "generic_name": "COMPUTER-ASSISTED DIAGNOSTIC SOFTWARE FOR LESIONS SUSPICIOUS FOR CANCER", "manufacturer_d_name": "", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "VERSION 2.4, 2.4.1", "catalog_number": "1", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "POK", "device_age_text": "", "device_evaluated_by_manufacturer": "I", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer", "medical_specialty_description": "Radiology", "regulation_number": "892.2060", "device_class": "2" } } ], "product_problems": [ "Image Display Error/Artifact", "Application Program Freezes or Fails to Launch", "Image Display Error/Artifact", "Application Program Freezes or Fails to Launch" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20210115", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11195257", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary 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": "I", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "227993057", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "QUANTX SOFTWARE MAY ENTER INTO AN ERROR STATE IN WHICH MEDICAL IMAGES DISPLAYED TO THE USER ARE FROZEN IN PLACE. QUANTX SOFTWARE VERSION (B)(4) ENTER INTO AN ERROR STATE IN WHICH ONE VIEWPORT IS FROZEN IN PLACE. WHEN THIS ERROR OCCURS, QUANTX STOPS RESPONDING TO USER INPUTS TO MODIFY THE DISPLAY OF THE FROZEN IMAGE. THIS ERROR STATE IS REACHED THROUGH A SPECIFIC SEQUENCE OF KEYSTROKES AND MOUSE ACTIONS. ONCE THE ONE IMAGE IS FROZEN IN A VIEWPORT IT REMAINS FROZEN. IT WILL ALSO REMAIN FROZEN IF A USER ATTEMPTS TO LOAD NEW PATIENT DATA. AS A RESULT OF THIS ERROR, USERS OF QUANTX WILL SEE AN INCORRECT OR INCOMPLETE IMAGE IN THE ONE FROZEN VIEWPORT. THIS ERROR STATE CAN BE RESOLVED BY CLOSING AND RELAUNCHING THE APPLICATION. THIS SOFTWARE LOGIC ERROR IS THE RESULT OF CODE THAT DOES NOT PROPERLY MODIFY IMAGE DISPLAY WHEN THE SPECIFIC SEQUENCE OF FUNCTIONS ARE CALLED OR CLEAR DATA HELD IN MEMORY WHEN NEW PATIENT DATA IS LOADED. THIS ERROR WAS OBSERVED BY QLARITY STAFF DURING A TRAINING SESSION AND DID NOT INVOLVE VIEWING LIVE PATIENT DATA. FDA SAFETY REPORT ID # (B)(4)." } ], "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": "" } ] }