{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "74686", "product_res_number": "Z-0342-2009", "event_date_initiated": "2008-08-29", "event_date_posted": "2009-01-05", "recall_status": "Terminated", "event_date_terminated": "2012-04-24", "res_event_number": "50083", "product_code": "JAA", "k_numbers": [ "K073542" ], "product_description": "GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. 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 ES-0372,  ES-0373,  ES-0386,  ES-0388,  ES-0389,  ES-0392,  ES-0393,  ES-0395,  ES-0396 ES-0397,  ES-0398,  ES-0406,  ES-0407,  ES-0408,  ES-0409,  ES-0410,  ES-0411,  ES-0414,  ES-0416,  ES-0420,  ES-0424,  ES-0426,  ES-0432,  ES-0440,  ES-0447,  ES-0448,  ES-0449,  ES-0453, ES-0457, ES-0466, ES-0470, ES-0471, ES-0473, ES-0474, ES-0475, ES-0477, ES-0481, ES-0489, ES-0491, ES-0492, ES-0503,  ES-0504, ES-0505, ES-0507, ES-0508, ES-0516,  ES-0517, ES-0519, ES-0520, ES-0530, ES-0531, ES-0537,  ES-0540, ES-0542, ES-0543, ES-0546, ES-0548, ES-7002-MH, and ES-7029-MH.", "firm_fei_number": "1720753", "recalling_firm": "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": "Under certain conditions, x-ray system may experience operational impairment.", "root_cause_description": "Device Design", "action": "Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.", "product_quantity": "448 units", "distribution_pattern": "Nationwide, including AK, KY, NC, VA WA. and WI", "openfda": { "k_number": [ "K840134", "K890745", "K922013", "K923453", "K081091", "K973073", "K913012", "K151485", "K801948", "K933472", "K970608", "K191713", "K992603", "K812963", "K111292", "K961193", "K884028", "K893644", "K973744", "K902982", "K944973", "K912341", "K024012", "K840364", "K930885", "K022911", "K993896", "K982028", "K813217", "K902980", "K910384", "K901671", "K926122", "K022899", "K922012", "K133434", "K820178", "K954590", "K950631", "K840191", "K812217", "K042698", "K132106", "K840390", "K925251", "K131075", "K875157", "K964322", "K912470", "K946081", "K883985", "K943447", "K954945", "K936236", "K953950", "K232526", "K982345", "K061028", "K233380", "K112054", "K802953", "K942674", "K945460", "K010392", "K871743", "K873985", "K941611", "K182834", "K933473", "K922274", "K961782", "K040870", "K771485", "K101491", 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