{ "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": "83813", "product_res_number": "Z-0457-2010", "event_date_initiated": "2009-07-30", "event_date_posted": "2009-11-25", "recall_status": "Terminated", "event_date_terminated": "2016-05-19", "res_event_number": "52720", "product_code": "IZZ", "k_numbers": [ "K884930" ], "product_description": "GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882.\n\nIntended to be used for general purpose radiography and tomography.", "code_info": 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00000062878ES4 082407220007\t 082407160038\t 082407160039\t 82407220007\t00000066163ES7 82407160038\t00000068268MA2 82407160039\t00000068269MA0 905842RAD\t00000064076ES3 416340ADVTX\t00000059658ES5 819855COMPAX\t00000069850MA6 418659COMPAX\t00000063221ES6 25980\t AH5290XR02\t 0910072061\t 910072061\t 00000066165ES2 0910072054\t 910072055\t 00000063271ES1 910072053\t 00000063272ES9 910072049\t 00000063269ES5, and  910072054\t 00000063273ES7.", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "262-544-3894", "reason_for_recall": "GE Healthcare has recently become aware that table lock safety features, which are provided with Compax\n40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement\nthat may impact patient safety.", "root_cause_description": "Other", "action": "Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare \"Urgent Medical device Correction\" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.", "product_quantity": "1046", "distribution_pattern": "Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.", "openfda": { "k_number": [ "K771601", "K827928", "K894188", "K971452", "K915413", "K920732", "K951315", "K924444", "K883974", "K861940", "K891403", "K912516", "K893452", "K921501", "K930273", "K893129", "K761339", "K772283", "K840156", "K884930", "K903921", "K951053", "K925174", "K952701", "K792169", "K834494", "K896665", "K912474", "K943926" ], "registration_number": [ "3014403439", "3029916061", "3027338963", "3000126629", "9616047", "1223864", "9616014", "3006551157", "3003768251", "9613445", "1450503", "1418964", "3012569470", "3005778458", "9617251", "9613299", "3004977335", "3008284470", "2243057", "2529571", "1317307", "3009715136", "9612283", "3032109181", "3003768277" ], "fei_number": [ "3002808529", "3014403439", "3029916061", "1000121370", "3027338963", "3000126629", "3002675731", "3006551157", "3003768251", "3002807880", "1000305755", "1450503", "1418964", "3012569470", "3005778458", "3003377038", "3002175190", "3002495042", "3004977335", "3008284470", "2243057", "3004571294", "3009715136", "1317307", "3032109181" ], "device_name": "Table, Radiographic, Non-Tilting, Powered", "medical_specialty_description": "Radiology", "regulation_number": "892.1980", "device_class": "2" } } ] }