{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150056", "product_res_number": "Z-0071-2017", "event_date_initiated": "2016-09-23", "event_date_posted": "2016-10-11", "recall_status": "Terminated", "event_date_terminated": "2017-04-24", "res_event_number": "75330", "product_code": "OXO", "k_numbers": [ "K123603" ], "product_description": "OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance\n\nProduct Usage:\nThe OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.", "code_info": "GE Brivo OEC715: Serial Numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051  GE Brivo OEC785: Serial Numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152  GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029", "firm_fei_number": "1720753", "recalling_firm": "GE OEC Medical Systems, Inc", "address_1": "384 N Wright Brothers Dr", "city": "Salt Lake City", "state": "UT", "postal_code": "84116-2862", "additional_info_contact": "Deena Pease\n801-536-4811", "reason_for_recall": "GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.", "root_cause_description": "Nonconforming Material/Component", "action": "GE Healthcare sent an Urgent Medical Device Correction letter dated September 23, 2016 to customers. The letter informed customers of the affected product, safety issue, and safety instructions for immediate mitigation of the issue. GE Healthcare will correct all affected products at no cost to customers. A GE Healthcare representative will the customers to arrange for the correction. Please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "148 total", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.", "openfda": { "k_number": [ "K010393", "K190024", "K003568", "K061873", "K051133", "K910115", "K940294", "K820658", "K900194", "K893617", "K935580", "K900193", "K253269", "K926056", "K934700", "K033066", "K172550", "K120388", "K880518", "K240828", "K120613", "K953910", "K896387", "K170946", "K911739", "K982706", "K892934", "K040066", "K183220", "K251004", "K243452", "K013426", "K993092", "K963093", "K913525", "K914748", "K253296", "K113708", "K213113", "K965013", "K233669", "K984406", "K760429", "K252579", "K250587", "K933431", "K973598", "K160131", "K092564", "K900967", "K933447", "K051754", "K951765", "K051490", "K163429", "K041213", "K203346", "K121303", "K003837", "K123603", "K921255", "K171800", "K131423", "K141672", "K182626", "K151280", "K960198", "K160065", "K133174", "K980322", "K050996", "K043379", "K040347", "K003266", "K060344", "K981131", "K192819", "K160984", "K955251", "K960907", "K010762", "K992506" ], "registration_number": [ "9613445", "3005877899", "3010462278", "3010703925", "3027339477", "1720753", "9611343", "3005172103", "3005843418", "3013099020", "3009715136", "3015223550", "3016619943", "3011491794", "1054713", "3018094310", "3008044777", "3027373189", "3010162973", "3008284470", "3021060474", "1723170", "3033525987", "3015276088", "3005496266", "1037955", "3005254598", "3018077344", "3006544299", "3004977335", "3003477135", "1222780", "3014279513", "3003768277", "3009196578", "3004198450", "3043048939", "3008496839", "3023003446", "3000126629", "3010685285", "3036666444", "3012624817", "3003202425", "3011416394", "9681146", "3003600763", "3005810333", "3008632256", "3011347852", "3017375271", "3009001657", "3012939903", "3035950510", "1225677", "8030233", "3011713200", "3010009632", "3036255956", "3030089787", "3010398867", "3031503890", "3004785967", "3012127758", "3042175844", "3015437189", "3021059265", "3002466018" ], "fei_number": [ "3001451453", "3005877899", "3010462278", "3010703925", "3027339477", "1720753", "3005172103", "3005843418", "3013099020", "3009715136", "3015223550", "3016619943", "3011491794", "3018094310", "3008044777", "3027373189", "1000114111", "1000284313", "3008284470", "3021060474", "3005254598", "3033525987", "3015276088", "3005496266", "1037955", "3018077344", "3006544299", "3004977335", "3003477135", "3014279513", "3002807041", "3009196578", "3004198450", "3043048939", "3008496839", "3023003446", "3000126629", "3010685285", "3002808139", "3012624817", "3036666444", "3003202425", "3002466018", "1000120743", "3011416394", "3002807880", "3003600763", "3005810333", "3008632256", "3011347852", "3017375271", "3009001657", "3012939903", "3035950510", "3011713200", "3010009632", "3005430103", "3036255956", "1000517638", "3030089787", "3010398867", "3031503890", "3004785967", "3012127758", "3042175844", "3015437189", "3021059265", "3002175190" ], "device_name": "Image-Intensified Fluoroscopic X-Ray System, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }