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U.S. Department of Health and Human Services

Class 2 Device Recall MULTISTAR P XRay System

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  Class 2 Device Recall MULTISTAR P 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-0139-2009
Recall Event ID 49426
510(K)Number K930635  
Product Classification angiographic x-ray system - Product Code IZI
Product MULTISTAR P X-Ray System, Model number 3773004.
Code Information Model number 3773004. Serial numbers: 1003, 1004, 1005, 1006, 1009, 1010, 1011, 1014, 1017, 1018, 1022, 1026, 1028, 1029, 1031, 1032, 1033, 1035, 1037, 1038, 1039, 1040, 1042, 1044, 1048, 1050, 1053, 1054, 1055, 1056, 1059, 1060, 1062, 1063, 1065, 1066, 1067, 1070, 1072, 1073, 1074, 1075, 1076, 1080, 1083, 1088, 1094, 1097, 1098, 1099, 1100, 1101, 1104, 1105, 1106, 1107, 1108, 1111, 1115, 1116, 1117, 1118, 1120, 1121, 1122, 1131, 1501, 1507, 1509, 1510, 1511, 1512, 1513, 1514, and 1515.
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 75 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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