Siemens Medical Solutions USA, Inc: 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.

Recall number

Z-1643-2008

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Status

Terminated

Initiated

2008-03-10

Posted

2008-08-24

Terminated

2008-11-19

Reason

The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.

Root cause

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K071114"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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