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U.S. Department of Health and Human Services

Class 2 Device Recall NEUROSTAR TOP XRay System

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  Class 2 Device Recall NEUROSTAR TOP 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-0148-2009
Recall Event ID 49426
510(K)Number K930635  
Product Classification angiographic x-ray system - Product Code IZI
Product NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668.
Code Information Model number 6258425 - Serial numbers: 1001, 1004, 1008, 1010, 1012, 1015, 1018, 1019, 1021, 1026, and 1029. Model number 6379668 - Serial numbers: 1109, 1111, 1119, 1121, 1122, 1123, 1126, 1127, 1128, 1130, 1134, 1135, 1137, 1140, 1141, 1142, 1143, 1144, 1147, 1149, 1151, 1152, 1154, 1155, 1156, 1159, 1163, 1165, 1171, 1173, 1174, 1175, 1176, 1179, 1180, 1181, 1185, 1190, 1192, 1194, 1195, 1196, 1201, 1205, 1208, and 1209.
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 57 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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