Device Recall syngo Imaging

  • Model / Serial
    Model number 10 014 063. Serial numbers: 1005, 1039, 1040, 1041, 1043, 1049, 1053, 1055, 1056, 1057, 1058, 1061, 1064, 1065, 1067, 1071, 1074, 1076, 1079, 1080, 1081, 1082, 1083, 1084, 1086, 1090, 1105, 1107, 1112, 1114, 1116, 1119, 1124, 1174, 1188, 1189, 1202, 1203, 1210, 1218, 1226, 1227, 1229, 1240, 1246, 1247, 1258, 1269, 1271, 1278, 1279, 1310, 1316, 1329, and 1334.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
    model number: 10014064 serial numbers: 5846 5847 4333 4334 4335
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in the states of NC and NE
  • Product Description
    SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
  • Manufacturer
  • Model / Serial
    material 10014063 Serial numbers: 1334, 1065, 1417, 1043 1353,1491,1496, 1316, 1279, 1116, 1090, 1081, 1310, 1226, 1396, 1107, 1343, 1198, 1432, 1058, 1082 1055, 1049, 1329, 1490, 1083, 1053, 1079, 1218, 1451, 1386, 1064, 1500, 1005, 1322, 1074. Updated version 31 contains 2 improvements on front end for usability, such as query enhancements and calibration improvements
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.
  • Product Description
    Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.
  • Manufacturer
  • Model / Serial
    Model number 10496279
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
  • Product Description
    syngo Imaging XS. || Radiological image processing system.
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Serial numbers: 1279, 1210, 1246, 1198, 1105, 1227, 1064, 1058, 1083, 1090, 1189, 1061, 1258, 1119, 1039, 1040, 1074, 1079, 1282 and 1056.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI.
  • Product Description
    syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. || Picture Archiving and communications system
  • Manufacturer
2 more