{ "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": 1218 } }, "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": "3002808157-2020-30667", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K081722", "date_of_event": "20180515", "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": [ "FOREIGN", "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "DA", "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": "465936", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "YSIO", "generic_name": "STATIONARY X-RAY SYSTEM", "manufacturer_d_name": "SIEMENS HEALTHCARE GMBH", "manufacturer_d_address_1": "HENKESSTRASSE 127", "manufacturer_d_address_2": "", "manufacturer_d_city": "ERLANGEN", "manufacturer_d_state": "", "manufacturer_d_zip_code": "91052", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "91052", "device_operator": "I", "model_number": "10281013", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "KPR", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, X-Ray, Stationary", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", null, "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": [ "Other" ], "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": "", "date_report": "20200414", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002531", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200414", "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": "202176463", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MOTOR CONTROLLER WITH SYSTEM VERSION VB10 WAS IDENTIFIED AS THE CAUSE OF THE ISSUE. A FAULTY MOTOR CONTROLLER MAY CAUSE INCORRECT SYSTEM POSITIONING. INCORRECT SYSTEM POSITIONING IS NOT PERMANENT; IT IS SPORADIC AND LASTS SHORT PERIOD OF TIME. HOWEVER, WHEN A MOVEMENT COMMAND IS TRIGGERED AND AN INCORRECT VALUE OF THE MOTOR CONTROLLER IS PRESENT, THE MOVEMENT IS NOT EXECUTED FOR THE ACTUAL POSITIONING OF THE CEILING STAND BUT BASED ON THE INCORRECT POSITION VALUE. DEPENDING ON THE DEVIATION BETWEEN THE REAL POSITION AND THE INCORRECT POSITION, THE CEILING STAND CAN MOVE AWAY FROM THE OPERATOR AFTER THE MOVEMENT COMMAND WAS TRIGGERED. IT WILL DRIVE OVER A STOP POSITION SPECIFIED BY THE SYSTEM AND INTO THE MECHANIC END STOP. SIEMENS HAS PREPARED A SOFTWARE SOLUTION TO DETECT INCORRECT POSITION VALUE OF THE CEILING STAND. THIS SOFTWARE WILL HELP AVOID INCORRECT SYSTEM MOVEMENT RESULTING FROM THIS ERROR. THIS SOFTWARE WAS ROLLED OUT FOR ALL AFFECTED SYSTEMS WITH THE FIELD UPDATE INSTRUCTION XP045/19/S. CONCERNED CUSTOMER SITES ARE BEING INFORMED ABOUT THE ISSUE AND AVAILABLE SOLUTION WITH A FIELD SAFETY NOTICE DISTRIBUTED VIA AN UPDATE INSTRUCTION XP044/19/S. THE FIELD CORRECTIVE ACTION WAS REPORTED TO FDA UNDER C&R # 2240869-02/11/2020-0008-C. (B)(4)." }, { "mdr_text_key": "202176464", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SIEMENS WAS INFORMED ABOUT UNINTENDED SYSTEM MOVEMENT OF THE YSIO UNIT. THE SYSTEM MOVED BY ITSELF TO A WALL DURING CLEANING. FOLLOWING THE SYSTEM RESTART, THE UNIT WAS FUNCTIONING PROPERLY. SIEMENS ACQUIRED ADDITIONAL KNOWLEDGE ABOUT THE CASE DURING INVESTIGATION OF THE CORRECTIVE ACTION; AND RE-EVALUATED THE RISK ASSOCIATED WITH THIS INCIDENT (B)(6) 2020. DUE TO A FAILURE IN AN INTERNAL COMPONENT (MOTOR CONTROLLER) THAT MAY CAUSE UNINTENDED SYSTEM MOVEMENT AND RESULT IN A POTENTIAL INJURY, THE ASSOCIATED RISK WAS ACCESSED AT HIGHER LEVEL AND THE INCIDENT WAS DEEMED AS A REPORTABLE ADVERSE EVENT. THERE NO INJURIES ATTRIBUTED TO THIS EVENT. SIEMENS IS NOT AWARE OF PATIENT INVOLVEMENT IS THIS CASE. THE REPORTED EVENT OCCURRED IN (B)(6)." } ], "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": "" } ] }