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Mobilett XP, mobile X-ray system, Model number 1818454 recallZ-0749-2007 · Siemens Medical Solutions USA, Inc · initiated Mar 21, 2007

Terminated All recalls posted in April 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0749-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 21, 2007
Posted by the FDA
Apr 19, 2007
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
186 units
Product code
IZL
FDA submissions
K033238
Distribution
The products were shipped to medical facilities nationwide.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

2 devices cleared under K033238 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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