Siemens Medical Solutions USA, Inc syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Siemens Medical Solutions USA, Inc is recalling syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063 due to Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability, inaccurate results during image measurements, incorrect review or diagnosis of displayed or printed images, measurement inaccuracies from the host modality and image
Recommended Action
Per FDA guidance
syngo Imaging has issued an Addendum to the User Manual, which was distributed to affected customers via Update Instructions IM118/08/S in November, 2008. Two safety related hotfixes (VB20G_HF4 and VB30A_HF26) will be released to those affected only after Update Instructions IM118/08/S has been performed. The addendum informs the user about safety relevant notes which pertain to syngo Imaging versions VB20G and VB30A. Update is a prerequisite for the following safety related hotfixes: VB20G_HF4 and VB30A_HF26.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026