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U.S. Department of Health and Human Services

Class 2 Device Recall ANGIOSTAR XRay System

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  Class 2 Device Recall ANGIOSTAR 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-0133-2009
Recall Event ID 49426
510(K)Number K884912  
Product Classification angiographic x-ray system - Product Code IZI
Product ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668.
Code Information Model number 9359142. Serial numbers: 999, 1038, 1062, 1068, 1073, 1104, 1106A, 1111, 1154, 1163, 1164, 1167, 1188, 1194, 1214, 1220, 1225, 1227, 1250, 1251, 1264, 1266, 1275, 1287, 1291, 1300, 1301, 1303, 1304, 1317, 1327, 1347, 1362, 1363, 1368, 1370, 1372, 1375, 1381, 1384, 1390, 1397, 1399, 1400, 1403, 1407, 1408, 1413, 1431, 1437, ASPP1_PT 01176, AS_P1_PT 01179, and AS2P8_PT 01185.
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 53 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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