notyard
09-04-2008, 08:23 AM
FDA class II recall:
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. Model number 7502029, Recall # Z-1643-2008
CODE
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
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on March 6, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
The selected patient images on the device may display an additional image from another patient or study.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Nationwide
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. Model number 7502029, Recall # Z-1643-2008
CODE
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
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on March 6, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
The selected patient images on the device may display an additional image from another patient or study.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Nationwide