CLASS II Device recall · Reported 8 Feb 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, distributed nationwide in the US. The recall was initiated on 11 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

Quantity recalled62 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-1116-2017
FDA event ID: 76278
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2017
FDA classified: 31 Jan 2017
Reported: 8 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Jan 2017	Recall initiated by company
31 Jan 2017	Classified by FDA	+20 days
8 Feb 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

Software update for improvements and to resolve 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 communications system.

Where it was distributed

Distributed throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

Software update for improvements and to resolve several issues

Which lots are affected?

Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

Where was it sold?

Distributed throughout the United States.

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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