Z-2264-2012Class II

syngo Imaging XS. Radiological image processing system

Name: Z-2264-2012 syngo Imaging XS. Radiological image processing system
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 Imaging XS. Radiological image processing system on 2012-07-18. FDA classified it as Class II and gives the reason as "There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest"...". 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-2264-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Posted: 2012-08-24
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Imaging XS. Radiological image processing system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep..
Quantity in commerce: 52
Distribution: Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Product codes and lots: Model number 10496279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2264-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2264-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-24

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)