Recalls / —

—#51335

Product

Mobilett XP, mobile X-ray system, Model number 1818454

FDA product code

IZL — System, X-Ray, Mobile

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K033238

Affected lot / code info

Serial numbers 1109, 1153, 1205, 2128, 1075, 1315, 1316, 1335, 1130, 1281, 1282, 1176, 1339, 1224, 1301, 2008, 1021, 1154, 1180, 1181, 1009, 1189, 1211, 1212, 2003, 2010, 1341, 1342, 2049, 2077, 2108, 1314, 1334, 1192, 1213, 1043, 1126, 1135, 2047, 2090, 2123, 1024, 1031, 1034, 1035, 1111, 2004, 1113, 1178, 1240, 1261, 2040, 1058, 1115, 1159, 1203, 1247, 1309, 1345, 2032, 1010, 1049, 1151, 1297, 1298, 2051, 1206, 1218, 1238, 1332, 1333, 2034, 2035, 2065, 1138, 1299, 1300, 2020, 2021, 2022, 2052, 2017, 2027, 1086, 1029, 1145, 1027, 1164, 1234, 2115, 1110, 1152, 1156, 1235, 1089, 1022, 1241, 1254, 1286, 1073, 1079, 1084, 1131, 1165, 1208, 2028, 2120, 2124, 2132, 1037, 1045, 1185, 1251, 1252, 1259, 1294, 1295, 2048, 1025, 1087, 1146, 1173, 1186, 1187, 1198, 1199, 1258, 1275, 1307, 2009, 1042, 1060, 1076, 1092, 1228, 1229, 1230, 1231, 1239, 1246, 1078, 2080, 2109, 2113, 1088, 1103, 1049, 1040, 1055, 1059, 1090, 1177, 1204, 1210, 1214, 1216, 1263, 1284, 1285, 1289, 1290, 1306, 1308, 2029, 2041, 2042, 2075, 2099, 2110, 1023, 1050, 1267, 1336, 1277, 1278, 1279, 1280, 2093, 1028, 1080, 1217, 1349, 1136, 1137, 1143, and 2100.

Why it was recalled

Mounting bolts for tank fork assembly and collimator flange may become loose.

Root cause (FDA determination)

Other

Action the firm took

Siemens Service Personnel are visiting each consignee, beginning March 21, 2007, to replace the required mounting bolts and tighten them according to required torque specifications.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The products were shipped to medical facilities nationwide.

Timeline

Recall initiated

2007-03-21

Posted by FDA

2007-04-19

Terminated

2007-08-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #51335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.