{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122081", "product_res_number": "Z-0066-2014", "event_date_initiated": "2013-09-18", "event_date_posted": "2013-10-24", "recall_status": "Terminated", "event_date_terminated": "2014-01-27", "res_event_number": "66341", "product_code": "OXO", "k_numbers": [ "K123603" ], "product_description": "GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus.\r\n\r\nThe QEC 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.", "code_info": "GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015", "firm_fei_number": "3002175190", "recalling_firm": "GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD", "address_1": "No. 2 Yong Chang North Rd. econ. & tech. dev. zone north rd.", "city": "Beijing", "country": "China", "additional_info_contact": "Deena Pease\n801-295-4952", "reason_for_recall": "GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.", "root_cause_description": "Device Design", "action": "GE Healthcare sent an Urgent Medical Device Correction letter dated September 18,2013, to all affected customers to inform them of the issue and provide instructions for immediate mitigation of the issue. Customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions. Customers with questions were instructed to call 1-800-874-7378 option 8.\r\nFor questions regarding this recall call 801-295-4952.", "product_quantity": "29", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.", "openfda": { "k_number": [ "K252579", "K010393", "K113708", "K160984", "K896387", "K013426", "K250587", "K980322", "K965013", "K892934", "K955251", "K933447", "K051490", "K253269", "K043379", "K182626", "K133174", "K893617", "K251004", "K951765", "K940294", "K900967", "K984406", "K061873", "K953910", "K981131", "K121303", "K973598", "K960198", "K192819", "K933431", "K141672", "K914748", "K963093", "K123603", "K131423", "K003266", "K051133", "K982706", "K910115", "K151280", "K913525", "K240828", "K040066", "K120613", "K171800", "K160065", "K003568", "K213113", "K092564", "K040347", "K203346", "K992506", "K921255", "K010762", "K934700", "K960907", "K050996", "K172550", "K183220", "K880518", "K900194", "K033066", "K911739", "K926056", "K003837", "K170946", "K060344", "K243452", "K190024", "K253296", "K160131", "K993092", "K163429", "K820658", "K900193", "K935580", "K120388", "K233669", "K760429", "K041213", "K051754" ], "registration_number": [ "3013099020", "3012624817", "3003600763", "3005496266", "3010703925", "3009001657", "3027339477", "3018094310", "9681146", "3010398867", "3043048939", "3017375271", "3031503890", "3042175844", "3005843418", "3030089787", "3006544299", "3021059265", "3035950510", "3000126629", "1723170", "3008044777", "8030233", "1225677", "3010685285", "3027373189", "3005172103", "3016619943", "3004785967", "3036666444", "3011713200", "9613445", "3018077344", "3005810333", "3033527282", "3003477135", "3011347852", "3004198450", "3036255956", "3011416394", "3002466018", "3008496839", "3009196578", "3010462278", "3008632256", "3021060474", "3005254598", "3011491794", "1222780", "3012939903", "1720753", "3008284470", "3015276088", "9611343", "1037955", "3010162973", "3033525987", "3004977335", "1054713", "3012127758", "3015223550", "3010009632", "3023003446", "3009715136", "3003202425", "3015437189", "3014279513", "3005877899", "3003768277" ], "fei_number": [ "3013099020", "3002807041", "1000114111", "3012624817", "3003600763", "3005430103", "3005496266", "3010703925", "3009001657", "3027339477", "3018094310", "3010398867", "3043048939", "3001451453", "3017375271", "3031503890", "3042175844", "3005843418", "3030089787", "3006544299", "3021059265", "3035950510", "3000126629", "3008044777", "3010685285", "3027373189", "3005172103", "1000284313", "3002808139", "3016619943", "3004785967", "3002807880", "3036666444", "3011713200", "3033527282", "3018077344", "3005810333", "3003477135", "3004198450", "3011347852", "3036255956", "3011416394", "1000120743", "3008496839", "3009196578", "3002466018", "1000517638", "3010462278", "3008632256", "3021060474", "3002175190", "3005254598", "3011491794", "3012939903", "1720753", "3008284470", "3015276088", "1037955", "3033525987", "3004977335", "3012127758", "3015223550", "3010009632", "3023003446", "3009715136", "3003202425", "3015437189", "3014279513", "3005877899" ], "device_name": "Image-Intensified Fluoroscopic X-Ray System, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }