Z-2111-2014Class II

Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication...

Name: Z-2111-2014 Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-06-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-06-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read... on 2014-06-30. FDA classified it as Class II and gives the reason as "Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest, Pixel...". 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-2111-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-30
Posted: 2014-07-23
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest, Pixel Lens, Edge enhancement and Histograms. This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel d
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer letter dated June 30th, to all affected customers to inform them of a new software version VA70B_0114 that will be introduced to all syngo Imaging XS customers with version VA70A or higher to solve a potential issue regarding miscalculations done for the grey scale values in the functions "Region of Interest", "Pixel Lens", "Edge Enhancement", and "Histograms". For questions regarding this recall call 610-219-6300.
Quantity in commerce: 141
Distribution: Nationwide Distribution
Product codes and lots: model number: 10496279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2111-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)