{ "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": 1051 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "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": "3015777306-2020-00001", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K080927", "date_of_event": "20200417", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "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": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20200417", "manufacturer_g1_state": "", "reporter_country_code": "BE", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "467114", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "BRIGHTVIEW", "generic_name": "SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION", "manufacturer_d_name": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "manufacturer_d_address_1": "VEENPLUIS 4-6", "manufacturer_d_address_2": "", "manufacturer_d_city": "BEST", "manufacturer_d_state": "", "manufacturer_d_zip_code": "5684", "manufacturer_d_zip_code_ext": "PC", "manufacturer_d_country": "NL", "manufacturer_d_postal_code": "5684 PC", "device_operator": "HEALTH PROFESSIONAL", "model_number": "BRIGHTVIEW XCT", "catalog_number": "882482", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "KPS", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3015777306" ], "fei_number": [ "3015777306" ], "device_name": "System, Tomography, Computed, Emission", "medical_specialty_description": "Radiology", "regulation_number": "892.1200", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Unintended System Motion" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000402", "removal_correction_number": "", "number_devices_in_event": "", "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": "317680555", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED, AT C.H.C. - CLINIQUE DU MONTLÉGIA, DURING SYSTEM INSTALLATION HE EXPERIENCED REVERSE GANTRY ROTATION DURING A CENTER OF ROTATION (COR) CALIBRATION IN THE 90° ORIENTATION. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO HARM AS A RESULT OF THIS EVENT. THE FSE CONFIRMED THAT A HARD LIMIT WAS REACHED DURING THE COR AND WAS ABLE TO RECOVER THE SYSTEM FROM THE LIMIT SWITCHES THAT WERE ACTIVATED. THE FSE EVALUATED THE SYSTEM AND CONFIRMED THAT THE REVERSE GANTRY ROTATION ONLY OCCURRED ONCE, COULD NOT BE REPRODUCED, AND HAS NOT RECURRED. LOGFILES WERE CAPTURED AND SENT FOR ENGINEERING REVIEW. ENGINEERING CONCLUDED FROM THE DETAILS PROVIDED, THE ISSUE OCCURRED DURING COR 90 CALIBRATION AND THE SYSTEM HALTED UPON REACHING THE HARD LIMITS. THE UNCOMMANDED GANTRY REVERSE ROTATION OCCURS VERY RARELY IN THE NORMAL USE CONDITIONS. FURTHERMORE, THE GANTRY REVERSE ROTATION IS NOT SPONTANEOUS, BUT A CONTINUATION OF THE COMMANDED MOTION BY THE USER AND IS DETECTABLE. THE SYSTEM HAS COLLISION SENSORS, HARDWARE AND SOFTWARE TRAVEL RANGE LIMITS AND EMERGENCY STOP CONTROLS WHICH CAN BE RELIED ON FOR THE USER TO STOP SYSTEM MOTIONS. PER THE INSTRUCTIONS FOR USE (IFU): BEFORE YOU START A STUDY, MAKE SURE THAT THE EQUIPMENT CAN PROCEED THROUGH ITS FULL RANGE OF INTENDED MOTIONS WITHOUT COMING INTO CONTACT WITH THE PATIENT OR OBJECTS. THE EMERGENCY STOP BUTTONS ACTIVATE QUICKLY TO STOP DETECTOR AND GANTRY MOTIONS. MAKE SURE THAT YOU ARE FAMILIAR WITH THE LOCATION OF THE EMERGENCY STOP BUTTONS, AND DO NOT HESITATE TO USE THEM." }, { "mdr_text_key": "317680556", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED FROM THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS THAT SYSTEM WAS EXPERIENCING GANTRY ROTATION GOING IN OPPOSITE DIRECTION THAN EXPECTED. THERE WAS NO PATIENT OR USER HARMED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT." }, { "mdr_text_key": "218018494", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED FROM THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS THAT SYSTEM WAS EXPERIENCING GANTRY ROTATION GOING IN OPPOSITE DIRECTION THAN EXPECTED. THERE WAS NO PATIENT OR USER HARMED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT." } ], "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": "05/01/2020" } ] }