{ "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": "85317", "product_res_number": "Z-0166-2010", "event_date_initiated": "2009-07-01", "event_date_posted": "2009-11-10", "recall_status": "Terminated", "event_date_terminated": "2010-01-12", "res_event_number": "53353", "product_code": "IZI", "k_numbers": [ "K884912" ], "product_description": "Koodinat M/MP Patient Table used with Angiostar Model 5294009.\n\nThe device is used as an Angiographic X-Ray System.", "code_info": "Model number 5294009. Serial numbers: 1001, 1004, 1017, 1019, 1024, 1029, 1033, 1038, 1040, 1042, 1048, 1055, 1056, 1060, 1062, 1066, 1067, 1070, 1075, 1083, 1085, 1088, 1090, 1092, 1093, 1094, 1101, 1102, 1103, 1104, 1105, 1107, 1108, 1113, 1115, 1116, 1117, 1119, 1123, 1126, 1127, 1130, 1134, 1138, 1143, 1144, 1146, 1147, 1148, 1149, 1152, 1157, 1158, 1160, 1166, 1167, 1173, 1177, 1178, 1180, 1184, 1186, 1192, 1196, 1207, 1213, 1214, 1216, 1217, 1226, 1229, 1231, 1233, 1234, 1235, 1236, 1237, 1238, 1240, 1245, 1247, 1248, 1250, 1256, 1262, 1263, 1265, 1266, 1281, 1283, 1289, 1290, 1292, 1293, 1294, 1296, 1297, 1300, 1302, 1303, 1305, 1308, 1312, 1314, 1319, 1321, and 1322.", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "51 Valley Stream Pkwy", "city": "Malvern", "state": "PA", "postal_code": "19355", "reason_for_recall": "The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.", "root_cause_description": "Labeling False and Misleading", "action": "The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.", "product_quantity": "107 units", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K810183", "K041027", "K030139", "K842494", "K930635", "K230727", "K972229", "K181537", "K945375", "K231986", "K875374", "K914376", "K944952", "K942503", "K812238", "K100849", "K970525", "K042646", "K955519", "K915232", "K945449", "K904540", "K934496", "K033184", "K982203", "K945400", "K993765", "K853044", "K882358", "K903372", "K842495", "K133719", "K910370", "K063345", "K052039", "K973482", "K875379", "K926258", "K082907", "K922804", "K243077", "K932410", "K903371", "K911732", "K072591", "K940484", "K083745", "K933058", "K850455", "K991922", "K926082", "K903941", "K813588", "K970738", "K062360", "K974679", "K811149", "K936002", "K923112", "K875376", "K924137", "K883831", "K945540", "K060749", "K897115", "K182907", "K984545", "K234090", "K960575", "K031333", "K052076", 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