Z-0522-2012

syngo.plaza Image processing system

Name: Z-0522-2012 syngo.plaza Image processing system
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-09-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-09-21 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo.plaza Image processing system on 2011-09-21. The reason FDA records is "Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these...". 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-0522-2012
Status: Terminated
Initiated: 2011-09-21
Posted: 2012-01-11
Terminated: 2014-01-31
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo.plaza Image processing system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.
Quantity in commerce: 1
Distribution: Nationwide Distribution New York
Product codes and lots: Model number 10592457

Product code LLZ

K093612Class IISyngo.plazaSiemens AG Medical Solutions / cleared 2010-03-04

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)