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U.S. Department of Health and Human Services

Class 2 Device Recall Koodinat M/MP Patient Table used with Angiostar

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  Class 2 Device Recall Koodinat M/MP Patient Table used with Angiostar see related information
Date Initiated by Firm July 01, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on January 12, 2010
Recall Number Z-0166-2010
Recall Event ID 53353
510(K)Number K884912  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Koodinat M/MP Patient Table used with Angiostar Model 5294009.

The device is used as an Angiographic X-Ray System.

Code Information 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.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
Manufacturer 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.
FDA Determined
Cause 2
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.
Quantity in Commerce 107 units
Distribution Nationwide Distribution.
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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