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

Syngo.plaza, Picture Archiving and Communications System(PACS) recalled

Siemens Medical Solutions USA is recalling Syngo.plaza, Picture Archiving and Communications System(PACS), distributed in Minnesota. The recall was initiated on 22 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesnon-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)

Quantity recalled2 units

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-0168-2018
FDA event ID: 77456
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 22 May 2017
FDA classified: 21 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

22 May 2017	Recall initiated by company
21 Nov 2017	Classified by FDA	+183 days
29 Nov 2017	Published in enforcement report	+8 days

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

Reason for recall

Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.

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), Model 10863171 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 work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

Where it was distributed

Distribution to MN

Minnesota

Questions about this recall

Why was it recalled?

Which lots are affected?

non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)

Where was it sold?

Distribution to MN

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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