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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo Imaging XS

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 Class 2 Recall
Siemens syngo Imaging XS
see related information
Date Posted February 20, 2012
Recall Status1 Terminated on September 29, 2012
Recall Number Z-1064-2012
Recall Event ID 61071
Premarket Notification
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, Pennsylvania 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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