CLASS II Device recall · Reported 5 Sep 2012 · FDA Enforcement Report

syngo Imaging XS recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling syngo Imaging XS. Radiological image processing system, distributed nationwide in the US. The recall was initiated on 18 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number 10496279

Quantity recalled52

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-2264-2012
FDA event ID: 62678
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2012
FDA classified: 24 Aug 2012
Reported: 5 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

18 Jul 2012	Recall initiated by company
24 Aug 2012	Classified by FDA	+37 days
5 Sep 2012	Published in enforcement report	+12 days

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

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".

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

syngo Imaging XS. Radiological image processing system.

Where it was distributed

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.

Nationwide California Colorado Connecticut Florida Georgia Iowa Illinois Indiana Kansas Maryland Minnesota Missouri North Carolina Nebraska New Jersey Nevada New York Ohio Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

Model number 10496279

Where was it sold?

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.

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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