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U.S. Department of Health and Human Services

Class 2 Device Recall Mobilett XP

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  Class 2 Device Recall Mobilett XP see related information
Date Initiated by Firm March 21, 2007
Date Posted April 19, 2007
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0749-2007
Recall Event ID 37698
510(K)Number K033238  
Product Classification mobile X-ray system - Product Code IZL
Product Mobilett XP, mobile X-ray system, Model number 1818454
Code Information 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.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-4500
Manufacturer Reason
for Recall		 Mounting bolts for tank fork assembly and collimator flange may become loose.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 186 units
Distribution The products were shipped to medical facilities nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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