Z-2275-2012Class II

syngo.plaza, Model number 10592457

Name: Z-2275-2012 syngo.plaza, Model number 10592457
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-07-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-07-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo.plaza, Model number 10592457. Intended use: radiological image processing system on 2012-07-18. FDA classified it as Class II and gives the reason as "There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions". 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-2275-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Posted: 2012-08-27
Terminated: 2014-01-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.
Quantity in commerce: 14
Distribution: Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Product codes and lots: Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2275-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

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)