CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report

Siemens syngo Imaging XS recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Siemens syngo Imaging XS, distributed nationwide in the US. The recall was initiated on 30 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmodel number: 10496279

Quantity recalled141

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2111-2014
FDA event ID: 68769
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2014
FDA classified: 23 Jul 2014
Reported: 30 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

30 Jun 2014	Recall initiated by company
23 Jul 2014	Classified by FDA	+23 days
30 Jul 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

model number: 10496279

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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