Z-2891-2016Class II

Syngo.plaza, Picture Archiving and Communication System

Name: Z-2891-2016 Syngo.plaza, Picture Archiving and Communication System
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-09-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-09-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza, Picture Archiving and Communication System on 2016-09-06. FDA classified it as Class II and gives the reason as "Software upgrade to eliminate several issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2891-2016
Classification: Class II
Status: Terminated
Initiated: 2016-09-06
Posted: 2016-09-27
Terminated: 2017-05-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza, Picture Archiving and Communication System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software upgrade to eliminate several issues
Root cause tag: software
FDA root cause: Software design
Action: Siemens notified customers via mail on 09/07/2016 informing them of the latest syngo.plaza software change that was available to address several issues.
Quantity in commerce: 47 systems
Distribution: Distributed Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2891-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2891-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27
Z-2892-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27

Product code LLZ

K093612Class IISyngo.plazaSiemens AG Medical Solutions / cleared 2010-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)