Z-1235-2009

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

Name: Z-1235-2009 syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-01-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-01-12 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063 on 2009-01-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1235-2009
Status: Terminated
Initiated: 2009-01-12
Posted: 2009-04-28
Terminated: 2009-09-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 55 units
Distribution: Nationwide Distribution.
Product codes and lots: 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 code LLZ

K071114Class IISyngo Imaging (Version V30)Siemens AG Medical Solutions / cleared 2007-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)