CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report

Syngo.plaza Picture Archiving and Communication System (PACS) recalled

Siemens Medical Solutions USA is recalling Syngo.plaza Picture Archiving and Communication System (PACS), distributed nationwide in the US. The recall was initiated on 18 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSyngo.plaza with software version VB20A; Model numbers: 10863171, 10863172, 10863173

Quantity recalled47

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-0495-2018
FDA event ID: 79054
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Aug 2017
FDA classified: 31 Jan 2018
Reported: 7 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Aug 2017	Recall initiated by company
31 Jan 2018	Classified by FDA	+166 days
7 Feb 2018	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 update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device 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

USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.

Nationwide Alabama Connecticut Florida Kansas Louisiana Massachusetts Michigan Minnesota Missouri Mississippi Nebraska New York Ohio Oregon Pennsylvania Texas Wisconsin

Stores named: Walmart

Questions about this recall

Is Syngo.plaza Picture Archiving and Communication System (PACS) recalled?

Yes. Siemens Medical Solutions USA recalled Syngo.plaza Picture Archiving and Communication System (PACS) on 18 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0495-2018.

Why was it recalled?

Which lots are affected?

Syngo.plaza with software version VB20A; Model numbers: 10863171, 10863172, 10863173

Where was it sold?

USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.

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 21 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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