Class 2 Device Recall Siemens syngo Imaging XS

• Date Initiated by Firm: January 26, 2012
• Date Posted: February 20, 2012
• Recall Status: Terminated on September 29, 2012
• Recall Number: Z-1064-2012
• Recall Event ID: 61071
• 510(K)Number: K082430
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Siemens syngo Imaging XS. Radiological image processing system.
• Code Information: Model number 10496279 -- serial numbers 1344, 1744, 1187, 2981, 1361, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3061, 2323, 2254, 1088, 1089, 2194, 2195, 1213, 1214, 1188, 1189, 3086, 2626, 1828, 1624, 1625, 2878, 2365, 2366, 3087, 3088, 3089, 2500, 2971, 1424, 1425, 3093, 2890, 1371, 1372, 3062, 2267, 2268, 2269, 1856, 1857, 2695, 2696, 3010, 1373, 1374, 1375, 1376, 1377, 1713, 1712, 2408, 2409, 2559, 2560, 2561, 2562, 1735, 1668, 2098, 1190, 1418, 2069, 2698, 2769, 1884, 1381, 1382, 1378, 1379, 1380, 1165, 2310, 2311, 2312, 2448, 2449, 2450, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2324, 1940, 1395, 2901, 2897, 2898, 2899, 2900, 2934, 3017, 2144, 2145, 2146, 2147, 2148, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2200, 2201, 1383, 3050, and 3085.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Anastasia Mason; 610-219-4834
• Manufacturer Reason for Recall: In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisor
• FDA Determined Cause: Software design
• Action: Siemens Medical issued an "UPDATE INSTRUCTIONS SY055/11/S/UPDATE PACKAGE VA70B_0211" to all affected customers. The package described the product, problem, and instructions for customers to follow.
• Quantity in Commerce: 128
• Distribution: Nationwide Distribution-including the states of CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
• 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 = LLZ