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

syngo.plaza recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling syngo.plaza, 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 codesSerial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

Quantity recalled14

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-2275-2012
FDA event ID: 62679
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2012
FDA classified: 27 Aug 2012
Reported: 5 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 Jul 2012	Recall initiated by company
27 Aug 2012	Classified by FDA	+40 days
5 Sep 2012	Published in enforcement report	+9 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 in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

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.plaza, Model number 10592457. Intended use: radiological image processing system.

Where it was distributed

Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

Nationwide California Florida Georgia Massachusetts Minnesota Missouri New Jersey New York Ohio Washington Wisconsin

Questions about this recall

Why was it recalled?

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

Which lots are affected?

Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

Where was it sold?

Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, 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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