CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Syngo.plaza, Picture Archiving and Communications System recalled

Siemens Medical Solutions USA is recalling Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture, distributed nationwide in the US. The recall was initiated on 20 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212

Quantity recalled13 systems

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-1533-2017
FDA event ID: 76639
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2017
FDA classified: 22 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

20 Feb 2017	Recall initiated by company
22 Mar 2017	Classified by FDA	+30 days
29 Mar 2017	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

Software updates

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, Picture Archiving and Communications System (PACS) Syngo.plaza 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.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

Where it was distributed

Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA

Nationwide California Florida Indiana Massachusetts Missouri Pennsylvania Texas Wisconsin

Questions about this recall

Why was it recalled?

Software updates

Which lots are affected?

Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212

Where was it sold?

Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA

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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