Z-0465-2013Class II

Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System

Name: Z-0465-2013 Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-06-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-06-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System on 2012-06-20. FDA classified it as Class II and gives the reason as "Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename...". 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-0465-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-20
Posted: 2012-12-03
Terminated: 2014-01-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: [email protected].
Quantity in commerce: 15
Distribution: Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
Product codes and lots: Model number 10 592 457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0465-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0465-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

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)