—#80254

Product

syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K071114
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-01-12
Posted by FDA: 2009-04-28
Terminated: 2009-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.