Z-2078-2012Class II

Siemens syngo.plaza. Radiological image processing system

Name: Z-2078-2012 Siemens syngo.plaza. Radiological image processing system
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-02-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-02-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo.plaza. Radiological image processing system on 2012-02-24. FDA classified it as Class II and gives the reason as "Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error...". 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-2078-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-24
Posted: 2012-07-26
Terminated: 2014-01-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo.plaza. Radiological image processing system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.
Quantity in commerce: 2
Distribution: (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Product codes and lots: Model number 10592457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2078-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2078-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

Product code LLZ

K101666Class IISyngo. Plaza Va20aSiemens AG Medical Solutions / cleared 2010-08-10

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)