Class 2 Device Recall Bicor HiP XRay System

• Date Initiated by Firm: August 11, 2008
• Date Posted: November 04, 2008
• Recall Status: Terminated on December 21, 2012
• Recall Number: Z-0138-2009
• Recall Event ID: 49426
• 510(K)Number: K940484
• Product Classification: angiographic x-ray system - Product Code IZI
• Product: Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.
• Code Information: Model number 6379767 - Serial numbers: 2002, 2004, 2005, 2011, 2012, 2015, 2016, 2017, 2018, 2022, 2025, 2026, 2033, 2042, 2045, 2055, 2058, 2059, 2063, 2066, 2070, 2072, 2078, 2083, 2089, 2092, 2093, 2094, 2096, 2097, 2098, 2099, and 2101. Model number 6258383: Serial numbers: 1014, 1015, 1034, 1044, 1045, 1050, 1054, 1061, 1067, 1073, 1090, 1091, 1099, 1101, 1102, 1103, 1109, 1115, 1122, 1126, 1128, 1132, 1133, 1137, 1138, 1141, 1142, 1143, 1147, 1152, 1156, 1157, and 1162.
• 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: 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: 66 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