{ "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": "131285", "product_res_number": "Z-0841-2015", "event_date_initiated": "2014-09-15", "event_date_posted": "2015-01-13", "recall_status": "Terminated", "event_date_terminated": "2015-05-20", "res_event_number": "69660", "product_code": "OXO", "k_numbers": [ "K123603" ], "product_description": "GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product\n\nUsed for general surgical applications and musculoskeletal procedures to visualize.", "code_info": "GE OEC Brivo 865 Plus Serial Numbers:  B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4", "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": "801-536-4516", "reason_for_recall": "mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).", "root_cause_description": "Radiation Control for Health and Safety Act", "action": "Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will, without charge, perform a mA calibration on all affected systems in the USA to bring the product back into compliance. The details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit.\n\nShould customers have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8.", "product_quantity": "61 units installed in US", "distribution_pattern": "Worldwide Distribution", "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" } } ] }