CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report

Syngo.plaza. A Picture Archiving and Communication System recalled

Siemens Medical Solutions USA is recalling Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, distributed in Florida, Massachusetts, Wisconsin. The recall was initiated on 18 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029

Quantity recalled4

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-1354-2015
FDA event ID: 70596
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2015
FDA classified: 30 Mar 2015
Reported: 8 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 Feb 2015	Recall initiated by company
30 Mar 2015	Classified by FDA	+40 days
8 Apr 2015	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

Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

Product as listed by the FDA

Syngo.plaza. 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.

Where it was distributed

US Distribution: MA, WI, FL

Florida Massachusetts Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029

Where was it sold?

US Distribution: MA, WI, FL

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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