{ "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": "130741", "product_res_number": "Z-0195-2015", "event_date_initiated": "2014-10-03", "event_date_posted": "2014-11-07", "recall_status": "Terminated", "event_date_terminated": "2015-03-23", "res_event_number": "69474", "product_code": "OWB", "k_numbers": [ "K021049", "K022069", "K111551", "K132027" ], "product_description": "Series OEC 9800.\n\nThe Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.", "code_info": "Serial No: 82-0013,82-0045,82-0061,82-0071,82-0085,82-0122,82-0133,82-0190,82-0246,82-0357,82-0528,82-0533,82-0597,82-0626,82-0699,82-0702,82-0707,82-0718,82-0805,82-0818,82-0854,82-0855,82-0946,82-1040,82-1052,82-1062,82-1106,82-1133,82-1199,82-1292,82-1324,82-1348,82-1411,82-1453,82-1460,82-1526,82-1542,82-1608,82-1651,82-1658,82-1679,82-1709,82-1731,82-1773,82-1822,82-1867,82-1882,82-1905,82-1914,82-1979,82-2017,82-2018,82-2024,82-2030,82-2036,82-2049,82-2165,82-2169,82-2206,82-2225,82-2241,82-2279,82-2356,82-2388,82-2398,82-2454,82-2455,82-2459,82-2474,82-2535,82-2565,82-2603,82-2650,82-2655,82-2735,82-2751,82-2761,82-2767,82-2783,82-2851,82-2855,82-2909,82-2930,82-2945,82-2975,82-3003,82-3094,82-3096,82-3169,82-3210,82-3226,82-3232,82-3241,82-3319,82-3325,82-3377,82-3389,82-3395,82-3406,82-3424,82-3430,82-3456,82-3459,82-3500,82-3523,82-3534,82-3539,82-3569,82-3571,82-3629,82-3713,82-3748,82-3774,82-3826,82-3837,82-3851,82-3895,82-7048-MH,82-7066-MH,82-7103-MH,89-0028,89-0034,89-0037,89-0072,89-0105,89-0113,89-0135-RC,89-0184,89-0192,89-0308,89-0311,89-0316,89-0318,89-0388,89-0396,89-0427,89-0517,89-0586,89-0600,89-0623,89-0624,89-0642,89-0643,89-0743,89-0825,89-0827,89-0840,89-0843,89-0846,89-0866,89-0881,89-0894,89-0930,89-0947,89-0995,89-1023,89-1145,89-1157,89-1202,89-1204,89-1209,89-1260,89-1308,89-1327,89-1375,89-1392,89-1408,89-1411,89-1544,89-1652,89-1671,89-1698,89-1751,89-1804,89-1849,89-1868,89-1956,89-1964,89-1984,89-1986,89-2031,89-2050,89-2083,89-2085,89-2094,89-2118,89-2142,89-2170,89-2199,89-2244,89-2250,89-2336,89-2354,89-2459,89-2550,89-2555,89-2598,89-2623,89-2674,89-2682,89-2690,89-2695,89-2767,89-2777,89-2850,89-2862,89-2900,89-3031,89-3032,89-3124-N,89-3165,89-3171,89-3222,89-3252,89-3254,89-3311,89-3318,89-3346,89-3359,89-3367,89-3368,89-3419,89-3438,89-3531,8S-0014-C,8S-0026,8S-0029,8S-0058,8S-0059,8S-0070,8S-0113,8S-0162,8S-0224,8S-0232,8S-0389,8S-0467,8S-0511,8S-0529,8S-0531,8S-0549,8S-0605,8S-0755,8S-0766,8S-0782,8S-0858,8S-0876,8S-0933-C,8S-0997,8S-1000,8S-1015,8S-1147,8S-1165,8S-1166,8S-1192,8S-1427,8S-1447,8S-1509-C,8S-1565,8S-1585,8S-1897,8S-1907,8S-2008-N,8S-2053,8S-2062,8S-2092,8S-2103,8S-2107,8S-2232,8S-2234,8S-2268,8S-2310,8S-2385,8S-2408,8S-2432,8S-2445,8S-2471-C,8S-2491,8S-2530,8S-2543,8S-2550,8S-2554,8S-2564,8S-2618,8S-2650,8S-2651,8S-2671,8S-2675,8S-2695,8S-2701,8S-2734,8S-2746,8S-2770,8S-2792,8S-2798,8S-2819,8S-2835,8S-2861,8S-2862,8S-2914,8S-2922,8S-2984,8S-3004,8S-3048,8S-3055,8S-3088,8S-3143,8S-3162-H,8S-3219,8S-3272-H,8S-3289-H,8S-7102-MH,", "firm_fei_number": "1720753", "recalling_firm": "GE OEC Medical Systems, Inc", "address_1": "384 Wright Brothers Dr", "city": "Salt Lake City", "state": "UT", "postal_code": "84116-2862", "additional_info_contact": "Deena Pease\n801-536-4952", "reason_for_recall": "GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.", "root_cause_description": "Component design/selection", "action": "On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to\ncustomers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter\nwas sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and\nRadiologists, 3.) Radiology Department. Firm will track all\nservice requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.", "product_quantity": "311", "distribution_pattern": "Worldwide Distribution.", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", "K181943", "K130638", "K060259", "K200917", "K070834", "K170752", "K120073", "K103425", "K936180", "K181670", "K030544", "K183144", "K201172", "K041605", "K251199", "K252068", "K190768", "K221281", "K212159", "K243328", "K200022", "K152696", "K212557", "K260607", "K251523", "K142126", "K211191", "K133292", "K961374", "K190064", "K152697", "K923049", "K221335", "K240465", "K252229", "K211782", "K241572", "K921219", "K000221", "K240224", "K160279", "K200887", "K222070", "K183101", "K122234", "K211064", "K111551", "K203281", "K093688", "K082243", "K143225", "K203504", "K181966", "K083725", "K031637", "K223410", "K053279", "K152785", "K243411", "K190626", "K133535", "K142273", "K201743", "K201583", 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"3026391023", "3002808382", "3014279513" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }