{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "190934", "product_res_number": "Z-0654-2022", "event_date_initiated": "2021-12-16", "event_date_created": "2022-02-28", "recall_status": "Open, Classified", "res_event_number": "89253", "product_code": "IZI", "k_numbers": [ "K062360" ], "product_description": "Digital Angiography System Bransist safire\n\nGenerator Model D150GC-40", "code_info": "Generator Model: D150GC-40  Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581", "firm_fei_number": "1000125362", "recalling_firm": "Shimadzu Medical Systems", "address_1": "20101 S Vermont Ave", "city": "Torrance", "state": "CA", "postal_code": "90502-1328", "additional_info_contact": "Johnny Goossens\n310-217-8855 Ext. 130", "reason_for_recall": "Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.", "root_cause_description": "Process change control", "action": "On 12/13/2021, the firm sent an \"Urgent: Voluntary Medical Device Recall Notice\" to distributors who hand-delivered to customers informing them that there is a potential issue with the adjustment procedure for the calibration of the x-ray generators for the Digital Angiography Systems and occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards.\n\nCustomers are instructed to:\n-Check their systems for the affected generators.\n-Contact their distributor to schedule a system update and calibration.\n-If customers feel there are any issues with their system, they are asked to discontinue use of the system and contact their local service providers.\n\nThe Recalling Firm has identified that affected units and have informed the authorized service representatives. The authorized servicers should be contacting customers to schedule time to implement the corrective action (update and calibrate).\n\nCustomers can contact the Recalling Firm's National Technical Support at:\nToll Free: (844)487-2767 available 8:00 a.m. to 5:00 p.m. Monday thru Friday\n\nOn 01/07/2022, an updated \"Urgent: Voluntary Medical Device Recall Letter\" will be communicated to customer to provide additional instruction on how to identify an issue with their system which would indicated to cease using until the system has been corrected.", "product_quantity": "18", "distribution_pattern": "U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA\n\n O.U.S.: Not provided.", "openfda": { "k_number": [ "K896088", "K931170", "K170239", "K910370", "K920434", "K993763", "K945540", "K890348", "K884912", "K002840", "K923112", "K904540", "K910654", "K924137", "K971489", "K113034", "K903493", "K042646", "K920705", "K905518", "K915232", "K875184", "K922804", "K010721", 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"3012345110", "3003637092" ], "device_name": "System, X-Ray, Angiographic", "medical_specialty_description": "Radiology", "regulation_number": "892.1600", "device_class": "2" } } ] }