CLASS II Device recall · Reported 5 Oct 2016 · FDA Enforcement Report

Syngo.plaza, Picture Archiving and Communication System recalled

Siemens Medical Solutions USA is recalling Syngo.plaza, Picture Archiving and Communication System, distributed nationwide in the US. The recall was initiated on 6 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206

Quantity recalled47 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-2891-2016
FDA event ID: 75171
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Sep 2016
FDA classified: 27 Sep 2016
Reported: 5 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

6 Sep 2016	Recall initiated by company
27 Sep 2016	Classified by FDA	+21 days
5 Oct 2016	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

Software upgrade to eliminate several issues

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 Communication System

Where it was distributed

Distributed Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Software upgrade to eliminate several issues

Which lots are affected?

Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206

Where was it sold?

Distributed Nationwide

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.

Other products in this recall event

1 other product · FDA event 75171

Reported	Class	Recall	Company	Reason	Where
5 Oct 2016	CLASS II	Syngo.plaza VB10A, Picture Archiving and Communication System recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide

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