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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Imaging XS

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  Class 2 Device Recall syngo Imaging XS see related information
Date Initiated by Firm March 10, 2008
Date Posted August 24, 2008
Recall Status1 Terminated 3 on November 19, 2008
Recall Number Z-1643-2008
Recall Event ID 47524
510(K)Number K071114  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
Code Information Model number 7502029. Serial numbers: 9288, 9632, 9633, 9640, 9792, 10412, 10625, 11106, 11942, 12029, 12030, 12031, 12032, 12068, 12211, 12216, 12217, 12222, 12229, 12235, 12276, 12283, 12288, 12543, 12577, 12600, 12610, 12660, 12661, 12062, 12063, 12643, 12739, 12773, 12782, 12783, 12789, 13026, 13027, 13090, 13131, 13147, 13155, 13208, 13241, 13280, 13295, 13296, 13297, 13298, 13299, 13300, 13301, 13302, 13303, 13304, 13305, 13306, 13307, 13308, 13310, 13358, 13370, 13371, 13372, 13400, 13401, 13402, 13403, 13404, 13405, 13406, 13407, 13408, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13419, 13420, 13421, 13427, 13428, 13429, 13432, 13433, 13434, 13435, 13436, 13437, 13438, 13439, 13440, 13441, 13442, 13443, 13444, 13445, 13446, 13447, 13448, 13449, 13450, 13451, 13452, 13453, 13454, 13455, 13456, 13457, 13458, 13459, 13460, 13461, 13462, 13480, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13501, 13504, 13505, 13510, 13519, 13520, 13574, 13575, 13576, 13591, 13635, 13636, 13637, 13669, 13670, 13671, 13672, 13673, 13674, 13675, 13676, 13679, 13680, 13681, 13682, 13683, 13684, 13685, 13686, 13687, 13688, 13689, 13690, 13691, 13692, 13693, 13694, 13695, 13696, 13697, 13724, 13725, 13732, 13733, 13734, 13735, 13740, 13745, 13749, 13751, 13785, 13791, 13792, 13794, 13811, 13820, 13821, 13822, 13823, 13824, 13825, 13826, 13846, 13847, 13848, 13849, 13850, 13851, 13889, 13890, 13906, 13907, 13908, 13909, 13912, 13913, 13921, 13922, 13933, 13934, 13945, 13959, 13960, 13961, 13968, 13971, 13979, 13980, 13991, 13992, 13996, 13997, 13998, 13999, 14000, 14004, 14005, 14016, 14017, 14043, 14050, 14051, 14052, 14053, 14054, 14059, and 14066.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Catherine Moffa
610-448-1774
Manufacturer Reason
for Recall		 The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions IM011/08/S. The letter informs customers of the potential issue and provides instructions to detect its occurrence. A software update to correct the issue is already available. A service representative will visit affected sites to install the software update. If you have questions concerning the advisory letter or you did not receive a letter contact Alexander Vogel at +49 (9131) 84-3840 or alexander.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-06.
Quantity in Commerce 236 units
Distribution The product was shipped to medical facilities in AL, AZ, CA, CO, CT, FL, GA, IA, KS, KY, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, WI, and WV.
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 and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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