Z-0514-2012

syngo Imaging XS, all versions Radiological image processing system

Name: Z-0514-2012 syngo Imaging XS, all versions Radiological image processing system
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-09-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-09-20 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Imaging XS, all versions Radiological image processing system on 2011-09-20. The reason FDA records is "Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0514-2012
Status: Terminated
Initiated: 2011-09-20
Posted: 2012-01-11
Terminated: 2014-03-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Imaging XS, all versions Radiological image processing system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.
Quantity in commerce: 38
Distribution: Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Product codes and lots: Model number 10496279

Product code LLZ

K082430Class IISyngo Imaging XsSiemens AG Medical Solutions / cleared 2008-11-14

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)