{ "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": "211353", "product_res_number": "Z-0703-2025", "event_date_initiated": "2024-11-21", "event_date_posted": "2024-12-18", "recall_status": "Open, Classified", "res_event_number": "95846", "product_code": "OXO", "k_numbers": [ "K203346", "K233669" ], "product_description": "OEC 3D REF \n\nImage-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.", "code_info": "Product Name: OEC 3D\nGTIN code: 00195278096944\nLot/Serial Numbers / UDI codes:\nFBMHDX00436\t(01)00195278096944(11)240800(21)FBMHDX00436\nFBMHDX00352\t(01)00195278096944(11)240500(21)FBMHDX00352\nFBMHDX00455\t(01)00195278096944(11)240900(21)FBMHDX00455\nFBMHDX00384\t(01)00195278096944(11)240600(21)FBMHDX00384\nFBMHDX00434\t(01)00195278096944(11)240900(21)FBMHDX00434\nFBMHDX00443\t(01)00195278096944(11)240900(21)FBMHDX00443\nFBMHDX00407\t(01)00195278096944(11)240700(21)FBMHDX00407\nFBMHDX00363\t(01)00195278096944(11)240500(21)FBMHDX00363\nFBMHDX00424\t(01)00195278096944(11)240800(21)FBMHDX00424\nFBMHDX00442\t(01)00195278096944(11)240900(21)FBMHDX00442\nFBMHDX00321\t(01)00195278096944(11)240300(21)FBMHDX00321\nFBMHDX00387\t(01)00195278096944(11)240600(21)FBMHDX00387\nFBMHDX00339\t(01)00195278096944(11)240400(21)FBMHDX00339\nFBMHDX00448\t(01)00195278096944(11)240900(21)FBMHDX00448\nFBMHDX00383\t(01)00195278096944(11)240600(21)FBMHDX00383\nFBMHDX00437\t(01)00195278096944(11)240900(21)FBMHDX00437\nFBMHDX00362\t(01)00195278096944(11)240500(21)FBMHDX00362\nFBMHDX00394\t(01)00195278096944(11)240600(21)FBMHDX00394\nFBMHDX00397\t(01)00195278096944(11)240700(21)FBMHDX00397\nFBMHDX00395\t(01)00195278096944(11)240700(21)FBMHDX00395\nFBMHDX00355\t(01)00195278096944(11)240500(21)FBMHDX00355\nFBMHDX00374\t(01)00195278096944(11)240600(21)FBMHDX00374\nFBMHDX00451\t(01)00195278096944(11)240900(21)FBMHDX00451\nFBMHDX00368\t(01)00195278096944(11)240500(21)FBMHDX00368\nFBMHDX00457\t(01)00195278096944(11)241000(21)FBMHDX00457\nFBMHDX00440\t(01)00195278096944(11)240900(21)FBMHDX00440\nFBMHDX00419\t(01)00195278096944(11)240800(21)FBMHDX00419\nFBMHDX00421\t(01)00195278096944(11)240800(21)FBMHDX00421\nFBMHDX00427\t(01)00195278096944(11)240800(21)FBMHDX00427\nFBMHDX00459\t(01)00195278096944(11)240900(21)FBMHDX00459\nFBMHDX00378\t(01)00195278096944(11)240600(21)FBMHDX00378\nFBMHDX00345\t(01)00195278096944(11)240400(21)FBMHDX00345\nFBMHDX00458\t(01)00195278096944(11)240900(21)FBMHDX00458\nFBMHDX00425\t(01)00195278096944(11)240800(21)FBMHDX00425\nFBMHDX00366\t(01)00195278096944(11)240500(21)FBMHDX00366\nFBMHDX00480\t(01)00195278096944(11)241100(21)FBMHDX00480\nFBMHDX00418\t(01)00195278096944(11)240800(21)FBMHDX00418\nFBMHDX00454\t(01)00195278096944(11)240900(21)FBMHDX00454\nFBMHDX00188\t(01)00195278096944(11)230300(21)FBMHDX00188\nFBMHDX00403\t(01)00195278096944(11)240700(21)FBMHDX00403\nFBMHDX00452\t(01)00195278096944(11)240900(21)FBMHDX00452\nFBMHDX00386\t(01)00195278096944(11)240600(21)FBMHDX00386\nFBMHDX00343\t(01)00195278096944(11)240400(21)FBMHDX00343\nFBMHDX00369\t(01)00195278096944(11)240500(21)FBMHDX00369\nFBMHDX00464\t(01)00195278096944(11)240900(21)FBMHDX00464\nFBMHDX00413\t(01)00195278096944(11)240800(21)FBMHDX00413\nFBMHDX00346\t(01)00195278096944(11)240400(21)FBMHDX00346\nFBMHDX00388\t(01)00195278096944(11)240600(21)FBMHDX00388\nFBMHDX00389\t(01)00195278096944(11)240600(21)FBMHDX00389\nFBMHDX00406\t(01)00195278096944(11)240700(21)FBMHDX00406\nFBMHDX00416\t(01)00195278096944(11)240800(21)FBMHDX00416\nFBMHDX00453\t(01)00195278096944(11)240900(21)FBMHDX00453\nFBMHDX00399\t(01)00195278096944(11)240700(21)FBMHDX00399\nFBMHDX00401\t(01)00195278096944(11)240700(21)FBMHDX00401\nFBMHDX00428\t(01)00195278096944(11)240800(21)FBMHDX00428\nFBMHDX00380\t(01)00195278096944(11)240600(21)FBMHDX00380\nFBMHDX00371\t(01)00195278096944(11)240600(21)FBMHDX00371\nFBMHDX00392\t(01)00195278096944(11)240600(21)FBMHDX00392\nFBMHDX00344\t(01)00195278096944(11)240400(21)FBMHDX00344\nFBMHDX00404\t(01)00195278096944(11)240700(21)FBMHDX00404\nFBMHDX00356\t(01)00195278096944(11)240500(21)FBMHDX00356\nFBMHDX00376\t(01)00195278096944(11)240600(21)FBMHDX00376\nFBMHDX00470\t(01)00195278096944(11)241000(21)FBMHDX00470\nFBMHDX00353\t(01)00195278096944(11)240500(21)FBMHDX00353\nFBMHDX00359\t(01)00195278096944(11)240500(21)FBMHDX00359\nFBMHDX00391\t(01)00195278096944(11)240600(21)FBMHDX00391\nFBMHDX00460\t(01)00195278096944(11)240900(21)FBMHDX00460\nFBMHDX00410\t(01)00840682121729(11)240700(21)FBMHDX00410\nFBMHDX00379\t(01)00195278096944(11)240600(21)FBMHDX00379\nFBMHDX00390\t(01)00195278096944(11)240600(21)FBMHDX00390\nFBMHDX00449\t(01)00195278096944(11)240900(21)FBMHDX00449\nFBMHDX00372\t(01)00195278096944(11)240600(21)FBMHDX00372\nFBMHDX00377\t(01)00195278096944(11)240600(21)FBMHDX00377\nFBMHDX00462\t(01)00195278096944(11)240900(21)FBMHDX00462\nFBMHDX00338\t(01)00195278096944(11)240400(21)FBMHDX00338\nFBMHDX00423\t(01)00195278096944(11)240800(21)FBMHDX00423\nFBMHDX00420\t(01)00195278096944(11)240800(21)FBMHDX00420\nFBMHDX00438\t(01)00195278096944(11)240900(21)FBMHDX00438\nFBMHDX00432\t(01)00195278096944(11)240900(21)FBMHDX00432\nFBMHDX00373\t(01)00195278096944(11)240600(21)FBMHDX00373\nFBMHDX00367\t(01)00195278096944(11)240500(21)FBMHDX00367\nFBMHDX00446\t(01)00195278096944(11)240900(21)FBMHDX00446\nFBMHDX00370\t(01)00195278096944(11)240600(21)FBMHDX00370\nFBMHDX00429\t(01)00195278096944(11)240800(21)FBMHDX00429", "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": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.", "root_cause_description": "Process control", "action": "On 11/21/2024, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\" Letter informing customers that GE HealthCare has become aware that recently manufactured OEC Elite and OEC 3D mobile C-arms, as well as recently replaced X-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/OEC 9800 mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability.\n\nCustomers are instructed to:\n1.Continue to use their OEC Elite, OEC 3D, OEC 9900 and/or OEC9800 mobile C-arm.\n2.If oil is found leaking from the X-ray tube on their OEC Elite, OEC 3D, OEC9900 and/or OEC 9800 mobile C-arm, contact the local GE HealthCareService representative.\n3.Ensure all potential users in their facility are made aware of this safety notification and the recommended actions.\n4.Please complete and return the attached acknowledgement form torecall.15150@gehealthcare.com.\n\nGE HealthCare will correct all affected products at no cost to you.\nA GE HealthCare representative will contact you to plan and schedule for the inspection and correction if needed.\n\nfor any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "84 systems", "distribution_pattern": "U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.\n\nO.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom", "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" } } ] }