CLASS II Device recall · Reported 12 Dec 2012 · FDA Enforcement Report

Siemens syngo.plaza Radiological Image Processing System recalled

Siemens Medical Solutions USA is recalling Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image, distributed nationwide in the US. The recall was initiated on 20 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number 10 592 457

Quantity recalled15

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-0465-2013
FDA event ID: 63521
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Jun 2012
FDA classified: 3 Dec 2012
Reported: 12 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Jun 2012	Recall initiated by company
3 Dec 2012	Classified by FDA	+166 days
12 Dec 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

Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could

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.plaza Radiological Image Processing System Usage: Radiological Image Processing System

Where it was distributed

Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.

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

Questions about this recall

Is Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image recalled?

Yes. Siemens Medical Solutions USA recalled Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image on 20 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-0465-2013.

Why was it recalled?

Which lots are affected?

Model number 10 592 457

Where was it sold?

Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, 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 21 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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