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U.S. Department of Health and Human Services

Class 2 Device Recall ANGIOSTAR Plus XRay System

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  Class 2 Device Recall ANGIOSTAR Plus XRay System see related information
Date Initiated by Firm August 11, 2008
Date Posted November 04, 2008
Recall Status1 Terminated 3 on December 21, 2012
Recall Number Z-0134-2009
Recall Event ID 49426
510(K)Number K884912  
Product Classification angiographic x-ray system - Product Code IZI
Product ANGIOSTAR Plus X-Ray System, Model number 6379718.
Code Information Model number 6379718. Serial numbers 1005, 1006, 1011, 1016, 1023, 1033, 1049, 1057, 1059, 1061, 1067, 1069, 1073, 1081, 1082, 1092, 1093, 1095, 1099, 1100, 1101, 1108, 1109, 1113, 1119, 1120, 1121, 1122, 1123, 1127, 1130, 1131, 1134, 1137, 1140, 1144, 1147, 1153, 1155, 1156, 1157, 1159, 1162, 1168, 1169, 1170, 1171, 1172, 1181, 1184, 1186, 1187, 1207, 1210, 1216, 1221, 1223, 1235, 1236, 1241, 1244, 1247, 1248, 1250, 1260, 1261, 1264, 1265, 1267, 1268, 1271, 1272, 1273, 1274, 1275, 1276, 1278, 1284, 1286, 1288, 1290, 1297, 1306, 1308, 1309, 1311, 1313, 1320, 1321, 1335, 1337, 1338, 1345, 1351, 1352, 1354, 1356, 1366, 1367, 1368, 1369, 1371, 1373, 1376, 1378, 1382, 1383, 1385, 1386, 1387, 1388, 1389, 1395, and 9004.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
Manufacturer Reason
for Recall		 Unintended movement of the system table and/or C arm.
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
Quantity in Commerce 114 units
Distribution 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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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