Z-1650-2009

syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063

Name: Z-1650-2009 syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-06-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-06-01 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063 on 2009-06-01. The reason FDA records is "Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations". 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-1650-2009
Status: Terminated
Initiated: 2009-06-01
Posted: 2009-07-07
Terminated: 2013-03-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.
Root cause tag: software
FDA root cause: Software design
Action: syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.
Quantity in commerce: 16 units
Distribution: Nationwide.
Product codes and lots: model number 10014063. Serial numbers: 1141, 1322, 1343, 1353, 1379, 1386, 1387, 1389, 1391, 1392, 1395, 1396, 1402, 1407, 1408, and 1417

Product code LLZ

K081734Class IISyngo Imaging (Version V31)Siemens AG Medical Solutions / cleared 2008-07-03

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)